alanine has been researched along with Hemorrhagic Fever, Ebola in 26 studies
Alanine: A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.
alanine : An alpha-amino acid that consists of propionic acid bearing an amino substituent at position 2.
Hemorrhagic Fever, Ebola: A highly fatal, acute hemorrhagic fever caused by EBOLAVIRUS.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Since the emergence of coronavirus disease 2019 (Covid-19), many studies have been performed to characterize severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and find the optimum way to combat this virus." | 2.66 | Remdesivir: A beacon of hope from Ebola virus disease to COVID-19. ( Farbod, A; Mahmoudi, H; Mozafarihashjin, M; Neishabouri, A; Nili, A; Tavakolpour, S, 2020) |
| "A major challenge in managing acute viral infections is ameliorating disease when treatment is delayed." | 1.72 | Combination therapy with remdesivir and monoclonal antibodies protects nonhuman primates against advanced Sudan virus disease. ( Abelson, DM; Agans, KN; Borisevich, V; Bornholdt, ZA; Bunyan, E; Campbell, LA; Cross, RW; Deer, DJ; Dobias, NS; Fenton, KA; Geisbert, JB; Geisbert, TW; Kim, DH; Porter, DP; Prasad, AN; Shestowsky, WS; Woolsey, C; Zeitlin, L, 2022) |
| "Efficacious therapeutics for Ebola virus disease are in great demand." | 1.62 | Remdesivir is efficacious in rhesus monkeys exposed to aerosolized Ebola virus. ( Bannister, R; Bavari, S; Cihlar, T; Donnelly, G; Garza, NL; Gomba, L; Iversen, PL; Kane, CD; Norris, S; Porter, DP; Steffens, J; Stuthman, KS; Van Tongeren, SA; Warren, TK; Weidner, JM; Wells, J; Zeng, X, 2021) |
| "Remdesivir has already been tested for Ebola virus disease treatment and found to have activity against SARS and MERS coronaviruses." | 1.56 | Development and validation of a UHPLC-MS/MS method for quantification of the prodrug remdesivir and its metabolite GS-441524: a tool for clinical pharmacokinetics of SARS-CoV-2/COVID-19 and Ebola virus disease. ( Antonucci, M; Avataneo, V; Cusato, J; D'Avolio, A; de Nicolò, A; di Perri, G; Lamorde, M; Manca, A; Palermiti, A; Waitt, C; Walimbwa, S, 2020) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 11 (42.31) | 24.3611 |
| 2020's | 15 (57.69) | 2.80 |
| Authors | Studies |
|---|---|
| Warren, TK | 4 |
| Kane, CD | 1 |
| Wells, J | 3 |
| Stuthman, KS | 3 |
| Van Tongeren, SA | 3 |
| Garza, NL | 2 |
| Donnelly, G | 2 |
| Steffens, J | 2 |
| Gomba, L | 2 |
| Weidner, JM | 1 |
| Norris, S | 1 |
| Zeng, X | 1 |
| Bannister, R | 3 |
| Cihlar, T | 5 |
| Bavari, S | 4 |
| Porter, DP | 3 |
| Iversen, PL | 1 |
| Fujita, Y | 1 |
| Cross, RW | 1 |
| Bornholdt, ZA | 1 |
| Prasad, AN | 1 |
| Woolsey, C | 1 |
| Borisevich, V | 1 |
| Agans, KN | 1 |
| Deer, DJ | 1 |
| Abelson, DM | 1 |
| Kim, DH | 1 |
| Shestowsky, WS | 1 |
| Campbell, LA | 1 |
| Bunyan, E | 1 |
| Geisbert, JB | 1 |
| Dobias, NS | 1 |
| Fenton, KA | 1 |
| Zeitlin, L | 1 |
| Geisbert, TW | 2 |
| Toroghi, MK | 1 |
| Al-Huniti, N | 1 |
| Davis, JD | 1 |
| DiCioccio, AT | 1 |
| Rippley, R | 1 |
| Baum, A | 1 |
| Kyratsous, CA | 1 |
| Sivapalasingam, S | 2 |
| Kantrowitz, J | 1 |
| Kamal, MA | 1 |
| Radoshitzky, SR | 1 |
| Iversen, P | 1 |
| Lu, X | 1 |
| Zou, J | 1 |
| Kaptein, SJF | 1 |
| Gong, R | 1 |
| Truong, H | 1 |
| Sapre, AA | 1 |
| Yang, H | 1 |
| Xie, X | 1 |
| Chia, JJ | 1 |
| Song, ZJ | 1 |
| Leventhal, SM | 1 |
| Chan, J | 1 |
| Shornikov, A | 1 |
| Zhang, X | 1 |
| Cowfer, D | 1 |
| Yu, H | 1 |
| Warren, T | 1 |
| Neyts, J | 1 |
| Shi, PY | 1 |
| Bilello, JP | 1 |
| Feng, JY | 3 |
| Lucey, DR | 1 |
| Mulangu, S | 1 |
| Dodd, LE | 1 |
| Davey, RT | 1 |
| Tshiani Mbaya, O | 1 |
| Proschan, M | 1 |
| Mukadi, D | 1 |
| Lusakibanza Manzo, M | 1 |
| Nzolo, D | 1 |
| Tshomba Oloma, A | 1 |
| Ibanda, A | 1 |
| Ali, R | 1 |
| Coulibaly, S | 1 |
| Levine, AC | 1 |
| Grais, R | 1 |
| Diaz, J | 1 |
| Lane, HC | 2 |
| Muyembe-Tamfum, JJ | 1 |
| Sivahera, B | 1 |
| Camara, M | 1 |
| Kojan, R | 1 |
| Walker, R | 1 |
| Dighero-Kemp, B | 1 |
| Cao, H | 2 |
| Mukumbayi, P | 1 |
| Mbala-Kingebeni, P | 1 |
| Ahuka, S | 1 |
| Albert, S | 1 |
| Bonnett, T | 1 |
| Crozier, I | 1 |
| Duvenhage, M | 1 |
| Proffitt, C | 1 |
| Teitelbaum, M | 1 |
| Moench, T | 1 |
| Aboulhab, J | 2 |
| Barrett, K | 1 |
| Cahill, K | 1 |
| Cone, K | 1 |
| Eckes, R | 1 |
| Hensley, L | 2 |
| Herpin, B | 1 |
| Higgs, E | 1 |
| Ledgerwood, J | 1 |
| Pierson, J | 1 |
| Smolskis, M | 1 |
| Sow, Y | 1 |
| Tierney, J | 1 |
| Holman, W | 1 |
| Gettinger, N | 1 |
| Vallée, D | 1 |
| Nordwall, J | 2 |
| Avataneo, V | 1 |
| de Nicolò, A | 1 |
| Cusato, J | 1 |
| Antonucci, M | 1 |
| Manca, A | 1 |
| Palermiti, A | 1 |
| Waitt, C | 1 |
| Walimbwa, S | 1 |
| Lamorde, M | 1 |
| di Perri, G | 1 |
| D'Avolio, A | 1 |
| Feldmann, H | 1 |
| Sprecher, A | 2 |
| Sarpatwari, A | 1 |
| Kaltenboeck, A | 1 |
| Kesselheim, AS | 1 |
| Malin, JJ | 1 |
| Suárez, I | 1 |
| Priesner, V | 1 |
| Fätkenheuer, G | 1 |
| Rybniker, J | 1 |
| Nili, A | 1 |
| Farbod, A | 1 |
| Neishabouri, A | 1 |
| Mozafarihashjin, M | 1 |
| Tavakolpour, S | 1 |
| Mahmoudi, H | 1 |
| Santoro, MG | 1 |
| Carafoli, E | 1 |
| Higgs, ES | 1 |
| Gayedyu-Dennis, D | 1 |
| Fischer Ii, WA | 1 |
| Nason, M | 1 |
| Reilly, C | 1 |
| Beavogui, AH | 1 |
| Lobbo, P | 1 |
| Wachekwa, I | 1 |
| Geraghty, RJ | 1 |
| Aliota, MT | 1 |
| Bonnac, LF | 1 |
| Yan, VC | 1 |
| Muller, FL | 1 |
| Gong, M | 1 |
| Yang, Y | 1 |
| Huang, Y | 1 |
| Gan, T | 1 |
| Wu, Y | 1 |
| Gao, H | 1 |
| Li, Q | 1 |
| Nie, J | 1 |
| Huang, W | 1 |
| Wang, Y | 1 |
| Zhang, R | 1 |
| Zhong, J | 1 |
| Deng, F | 1 |
| Rao, Y | 1 |
| Ding, Q | 1 |
| Check Hayden, E | 1 |
| Nakkazi, E | 1 |
| Dapiaggi, F | 1 |
| Pieraccini, S | 1 |
| Sironi, M | 1 |
| Jordan, R | 2 |
| Lo, MK | 2 |
| Ray, AS | 2 |
| Mackman, RL | 2 |
| Soloveva, V | 2 |
| Siegel, D | 2 |
| Perron, M | 2 |
| Hui, HC | 2 |
| Larson, N | 1 |
| Strickley, R | 2 |
| Shurtleff, AC | 1 |
| Retterer, CJ | 1 |
| Gharaibeh, D | 1 |
| Zamani, R | 1 |
| Kenny, T | 1 |
| Eaton, BP | 1 |
| Grimes, E | 1 |
| Welch, LS | 1 |
| Wilhelmsen, CL | 1 |
| Nichols, DK | 1 |
| Nuss, JE | 1 |
| Nagle, ER | 1 |
| Kugelman, JR | 1 |
| Palacios, G | 1 |
| Doerffler, E | 2 |
| Neville, S | 2 |
| Carra, E | 2 |
| Clarke, MO | 2 |
| Zhang, L | 2 |
| Lew, W | 2 |
| Ross, B | 2 |
| Wang, Q | 2 |
| Chun, K | 2 |
| Wolfe, L | 2 |
| Babusis, D | 1 |
| Park, Y | 1 |
| Stray, KM | 2 |
| Trancheva, I | 1 |
| Barauskas, O | 2 |
| Xu, Y | 2 |
| Wong, P | 1 |
| Braun, MR | 1 |
| Flint, M | 1 |
| McMullan, LK | 1 |
| Chen, SS | 1 |
| Fearns, R | 1 |
| Swaminathan, S | 2 |
| Mayers, DL | 1 |
| Spiropoulou, CF | 1 |
| Lee, WA | 2 |
| Nichol, ST | 1 |
| Jacobs, M | 1 |
| Rodger, A | 1 |
| Bell, DJ | 1 |
| Bhagani, S | 1 |
| Cropley, I | 1 |
| Filipe, A | 1 |
| Gifford, RJ | 1 |
| Hopkins, S | 1 |
| Hughes, J | 1 |
| Jabeen, F | 1 |
| Johannessen, I | 1 |
| Karageorgopoulos, D | 1 |
| Lackenby, A | 1 |
| Lester, R | 1 |
| Liu, RS | 1 |
| MacConnachie, A | 1 |
| Mahungu, T | 1 |
| Martin, D | 1 |
| Marshall, N | 1 |
| Mepham, S | 1 |
| Orton, R | 1 |
| Palmarini, M | 1 |
| Patel, M | 1 |
| Perry, C | 1 |
| Peters, SE | 1 |
| Porter, D | 1 |
| Ritchie, D | 1 |
| Ritchie, ND | 1 |
| Seaton, RA | 1 |
| Sreenu, VB | 1 |
| Templeton, K | 1 |
| Warren, S | 1 |
| Wilkie, GS | 1 |
| Zambon, M | 1 |
| Gopal, R | 1 |
| Thomson, EC | 1 |
| Cardile, AP | 1 |
| Martins, KA | 1 |
| Reisler, RB | 1 |
| Dörnemann, J | 1 |
| Burzio, C | 1 |
| Ronsse, A | 1 |
| De Clerck, H | 1 |
| Van Herp, M | 1 |
| Kolié, MC | 1 |
| Yosifiva, V | 1 |
| Caluwaerts, S | 1 |
| McElroy, AK | 1 |
| Antierens, A | 1 |
| Knox, J | 1 |
| Perry, J | 1 |
| Lee, G | 1 |
| Rheingold, AL | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Multicenter, Multi-Outbreak, Randomized, Controlled Safety and Efficacy Study of Investigational Therapeutics for the Treatment of Patients With Ebola Virus Disease[NCT03719586] | Phase 2/Phase 3 | 681 participants (Actual) | Interventional | 2018-11-21 | Completed | ||
| Antiviral Activity and Safety of Remdesivir in Bangladeshi Patients With Severe Coronavirus Disease (COVID-19): An Open Label, Multi-Center, Randomized Controlled Trial[NCT04596839] | Phase 2 | 60 participants (Actual) | Interventional | 2020-09-04 | Completed | ||
| Multicenter, Retrospective Study of the Effects of Remdesivir in the Treatment of Severe Covid-19 Infections.[NCT04365725] | 84 participants (Actual) | Observational | 2020-05-05 | Completed | |||
| PREVAIL IV: Double-Blind, Randomized, Two-Phase, Placebo-Controlled, Phase II Trial of GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen[NCT02818582] | Phase 2 | 38 participants (Actual) | Interventional | 2016-07-01 | Completed | ||
| Characterizing SARS-CoV-2 Persistence in Host Reservoirs, Post-viral Sequelae, and Associations With Host and Viral Determinants in a Cohort of Convalescent COVID-19 Cases[NCT04448145] | 325 participants (Anticipated) | Observational | 2020-03-26 | Recruiting | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
The number of Serious Adverse Events that were tentatively ascribed to one of the four treatment arms by the site investigator and, upon extensive further review and adjudication by an independent Pharmacovigilance committee, were still felt potentially attributable to study drug as opposed to the underlying Ebola infection. (NCT03719586)
Timeframe: up to Day 58
| Intervention | number of SAEs (Number) |
|---|---|
| Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | 1 |
| Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 0 |
| Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC) | 0 |
| Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC) | 3 |
Number of Participants with Mortality by Day 28 (NCT03719586)
Timeframe: 28 days
| Intervention | deaths (Number) |
|---|---|
| Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | 93 |
| Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 61 |
| Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC) | 52 |
| Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC) | 84 |
This was a measure of the median number of days that it took for the serum PCR to first turn negative after having been positive throughout the patient's earlier course. (NCT03719586)
Timeframe: up to Day 28
| Intervention | Days (Median) |
|---|---|
| Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | NA |
| Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 16 |
| Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC) | 15 |
| Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC) | 27 |
"These are the median CTnp pCR values measured serially on the 4 treatment arms as per protocol.~caveats: Undetectable ctNP values are imputed as ctNP=45.0 (the limit of detection). Missing values (due to gaps in sample collection, discharge, or death) are handled by carrying forward the last observation.~The Day 28 visit includes a ±7-day visit window. The priority for defining the ctNP value for this timepoint, according to days post-randomization, is: 28, 27, 29, 26, 30, 25, 31, 24, 32, 23, 33, 22, 34, 21. For example, the ctNP result from the sample collected 26 days post-randomization will only be used for this timepoint if there are no sample results for 28, 27, or 29 days post-randomization." (NCT03719586)
Timeframe: Days 1, 2, 3, 4, 6, 8, 10, 14, and 28.
| Intervention | median CTnp PCR values (Median) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ar randomization | Day 1 | Day 2 | Day 3 | Day 4 | Day 6 | Day 8 | Day 10 | Day 14 | Day 28 | |
| Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | 23.1 | 22.2 | 23.0 | 23.7 | 25.4 | 28.6 | 30.1 | 31.6 | 33.2 | 37.6 |
| Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 23.4 | 23.7 | 25.1 | 28.6 | 30.9 | 32.7 | 34.4 | 36.3 | 39.1 | 45.0 |
| Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC) | 22.8 | 23.3 | 25.2 | 28.1 | 30.5 | 32.7 | 34.5 | 36.3 | 39.8 | 45.0 |
| Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC) | 23.1 | 22.8 | 23.7 | 24.2 | 25.7 | 29.4 | 32.2 | 33.2 | 35.2 | 38.4 |
"Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase - weeks 8, 12, 16, 20, & 24. Average of all time points for negative values were compiled for the collected assay values.~Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate." (NCT02818582)
Timeframe: Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)
| Intervention | proportion of semen samples (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.95 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.9 |
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.33 |
"Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase on weeks 8, 12, 16, 20, & 24. Average of all time points for negative values were compiled for the collected assay values.~Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate." (NCT02818582)
Timeframe: Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)
| Intervention | proportion of semen samples (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.96 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.81 |
"Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, & 28. Average of all time points for negative values were compiled for the collected assay values.~Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate." (NCT02818582)
Timeframe: Treatment Phase (assessed at days 4, 8, 11, 16, 20, 24, & 28)
| Intervention | proportion of semen samples (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.85 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.76 |
"Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, & 28. Average of all time points for negative values were compiled for the collected assay values.~Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate." (NCT02818582)
Timeframe: Treatment Phase (assessed on days 4, 8, 11, 16, 20, 24, & 28)
| Intervention | proportion of semen samples (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.86 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.86 |
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.79 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.28 |
Mean change from baseline in alanine transaminase (ALT) value at at day 24 (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.65 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.67 |
Mean change from baseline in alanine transaminase (ALT) value at at day 28 (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.4 |
| Normal Saline Given Intravenously Daily for 5 Days | -2.06 |
Mean change from baseline in alanine transaminase (ALT) value at day 1 (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 3.6 |
| Normal Saline Given Intravenously Daily for 5 Days | -2.22 |
Mean change from baseline in alanine transaminase (ALT) value at day 16 (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 3.53 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.06 |
Mean change from baseline in alanine transaminase (ALT) value at day 2 (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 2.25 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.56 |
Mean change from baseline in alanine transaminase (ALT) value at day 3 (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 4.05 |
| Normal Saline Given Intravenously Daily for 5 Days | 10.28 |
Mean change from baseline in alanine transaminase (ALT) value at day 4 (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 8.45 |
| Normal Saline Given Intravenously Daily for 5 Days | 11.78 |
Mean change from baseline in alanine transaminase (ALT) value at day 5 (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 13.15 |
| Normal Saline Given Intravenously Daily for 5 Days | 9.22 |
Mean change from baseline in alanine transaminase (ALT) value at day 8 (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 21.45 |
| Normal Saline Given Intravenously Daily for 5 Days | 4.89 |
Mean change from baseline in alanine transaminase (ALT) Value at week 12 (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 3.1 |
| Normal Saline Given Intravenously Daily for 5 Days | -1.78 |
Mean change from baseline in alanine transaminase (ALT) value at week 16 (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 5.95 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.11 |
Mean change from baseline in alanine transaminase (ALT) value at week 20 (NCT02818582)
Timeframe: Follow-up phase - Week 20
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -1.55 |
| Normal Saline Given Intravenously Daily for 5 Days | -1.72 |
Mean change from baseline in alanine transaminase (ALT) value at week 24 (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.89 |
| Normal Saline Given Intravenously Daily for 5 Days | 22.67 |
Mean change from baseline in alanine transaminase (ALT) value at week 8 (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -2.15 |
| Normal Saline Given Intravenously Daily for 5 Days | -1.22 |
Mean change from baseline in alanine transaminase (ALT) value at day 11 (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 8.65 |
| Normal Saline Given Intravenously Daily for 5 Days | 1.78 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 1 (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.34 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.24 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 11 (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -1.41 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.17 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 16 (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.18 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.26 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 2 (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.9 |
| Normal Saline Given Intravenously Daily for 5 Days | -1.45 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 24 (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.27 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.76 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 28 (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.52 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.24 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 3 (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.03 |
| Normal Saline Given Intravenously Daily for 5 Days | -1.42 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 4 (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 3.82 |
| Normal Saline Given Intravenously Daily for 5 Days | -2.24 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 5 (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1.29 |
| Normal Saline Given Intravenously Daily for 5 Days | -1.24 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 8 (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 3.92 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.34 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 12 (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.5 |
| Normal Saline Given Intravenously Daily for 5 Days | 1.29 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 16 (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.78 |
| Normal Saline Given Intravenously Daily for 5 Days | 1.37 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 20 (NCT02818582)
Timeframe: Follow-up phase - Week 20
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1.83 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.75 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 24 (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.39 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.41 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 8 (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1.16 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.62 |
Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 12 (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 5.85 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 16 (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 11.4 |
| Normal Saline Given Intravenously Daily for 5 Days | 1.39 |
Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 20 (NCT02818582)
Timeframe: Follow-up phase - Week 20
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.95 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.67 |
Mean change from baseline in aspartate transaminase (AST) Value at day 1 (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 2.45 |
| Normal Saline Given Intravenously Daily for 5 Days | -1.89 |
Mean change from baseline in aspartate transaminase (AST) value at day 11 (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.2 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.22 |
Mean change from baseline in aspartate transaminase (AST) value at day 16 (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -1.42 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.89 |
Mean change from baseline in aspartate transaminase (AST) Value at day 2 (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.2 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.06 |
Mean change from baseline in aspartate transaminase (AST) value at day 24 (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -1.25 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.67 |
Mean change from baseline in aspartate transaminase (AST) value at day 28 (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.85 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.83 |
Mean change from baseline in aspartate transaminase (AST) value at day 3 (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.35 |
| Normal Saline Given Intravenously Daily for 5 Days | 10.39 |
Mean change from baseline in aspartate transaminase (AST) value at day 4 (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 5.6 |
| Normal Saline Given Intravenously Daily for 5 Days | 5.72 |
Mean change from baseline in aspartate transaminase (AST) value at day 5 (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 8.15 |
| Normal Saline Given Intravenously Daily for 5 Days | 2.44 |
Mean change from baseline in aspartate transaminase (AST) value at day 8 (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 9.4 |
| Normal Saline Given Intravenously Daily for 5 Days | 1.39 |
Mean change from baseline in aspartate transaminase (AST) value at week 24 (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -1.05 |
| Normal Saline Given Intravenously Daily for 5 Days | 11.61 |
Mean change from baseline in aspartate transaminase (AST) value at week 8 (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | IU/L (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -1.7 |
| Normal Saline Given Intravenously Daily for 5 Days | 1.39 |
Mean change from baseline in international normalized ratio (INR) value at day 1 (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.02 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Mean change from baseline in international normalized ratio (INR) value at day 11 (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.05 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.03 |
Mean change from baseline in international normalized ratio (INR) value at day 16 (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.05 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.05 |
Mean change from baseline in international normalized ratio (INR) value at day 2 (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.01 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.01 |
Mean change from baseline in international normalized ratio (INR) value at day 24 (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.06 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.04 |
Mean change from baseline in international normalized ratio (INR) value at day 28 (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.01 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.03 |
Mean change from baseline in international normalized ratio (INR) value at day 3 (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.03 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.03 |
Mean change from baseline in international normalized ratio (INR) value at day 4 (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1.04 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.06 |
Mean change from baseline in international normalized ratio (INR) value at day 5 (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.13 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.05 |
Mean change from baseline in international normalized ratio (INR) value at day 8 (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.12 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.05 |
Mean change from baseline in international normalized ratio (INR) value at week 12 (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.04 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.06 |
Mean change from baseline in international normalized ratio (INR) value at week 16 (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.09 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.05 |
Mean change from baseline in international normalized ratio (INR) value at week 20 (NCT02818582)
Timeframe: Follow-up phase - Week 20
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.05 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.16 |
Mean change from baseline in international normalized ratio (INR) value at week 24 (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.1 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.28 |
Mean change from baseline in international normalized ratio (INR) value at week 8 (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Ratio (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.01 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.18 |
Mean change from baseline in prothrombin time (PT) value at day 1 (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.13 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.22 |
Mean change from baseline in prothrombin time (PT) value at day 11 (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.08 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.04 |
Mean change from baseline in prothrombin time (PT) value at day 16 (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.13 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.17 |
Mean change from baseline in prothrombin time (PT) value at day 2 (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.09 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.13 |
Mean change from baseline in prothrombin time (PT) value at day 24 (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.1 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.07 |
Mean change from baseline in prothrombin time (PT) value at day 28 (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.34 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.11 |
Mean change from baseline in prothrombin time (PT) value at day 3 (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.28 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.01 |
Mean change from baseline in prothrombin time (PT) value at day 4 (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 6.27 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.24 |
Mean change from baseline in prothrombin time (PT) value at day 5 (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1.28 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.13 |
Mean change from baseline in prothrombin time (PT) value at day 8 (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0.86 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.11 |
Mean change from baseline in prothrombin time (PT) value at week 12 (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.22 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.06 |
Mean change from baseline in prothrombin time (PT) value at week 16 (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.17 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.03 |
Mean change from baseline in prothrombin time (PT) value at week 20 (NCT02818582)
Timeframe: Follow-up phase - Week 20
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.25 |
| Normal Saline Given Intravenously Daily for 5 Days | 0.26 |
Mean change from baseline in prothrombin time (PT) value at week 24 (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.41 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.23 |
Mean change from baseline in prothrombin time (PT) value at week 8 (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Seconds (Mean) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | -0.26 |
| Normal Saline Given Intravenously Daily for 5 Days | -0.27 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at day 1.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (AE) [DAIDS AE grading table] version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 11.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 3 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 16.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 2.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 24.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 28.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 3.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 4.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 3 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 5.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 2 |
| Normal Saline Given Intravenously Daily for 5 Days | 2 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 8.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 5 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 12.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 16.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 20.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 20
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at week 24.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
"Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 8.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 1.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 11.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 16.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 2.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 24.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 28.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 3.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 4.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 5 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 5.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 2 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 8.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 2 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 12.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 16.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 2 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 20.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 20
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 2 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 24.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
"Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 8.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 1.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 11.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 16.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 2.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 24.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 28.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 3.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 4 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 4.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 5.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 8.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 3 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 12.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 16.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 2 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at week 20.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 20
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 24.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
"Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 8.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), & grade 4 (> 10 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
"Number of participants increase in grade from baseline in prothrombin time (PT) value at day 24.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants increase in grade from baseline in prothrombin time (PT) value at day 28.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants increase in grade from baseline in prothrombin time (PT) value at week 12.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants increase in grade from baseline in prothrombin time (PT) value at week 16.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants increase in grade from baseline in prothrombin time (PT) value at week 20.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 20
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
"Number of participants increase in grade from baseline in prothrombin time (PT) value at week 24.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants increase in grade from baseline in prothrombin time (PT) value at week 8.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 1.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 11.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 16.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 2.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 3.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 4.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 2 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 5.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
"Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 8.~Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening).~PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), & grade 4 (> 3.00 x ULN)" (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 1 (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 11 (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 3 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 16 (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 2 (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 24 (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 28 (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 3 (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 5 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 4 (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 3 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 5 (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 2 |
| Normal Saline Given Intravenously Daily for 5 Days | 2 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 8 (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 4 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 12 (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 16 (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 20 (NCT02818582)
Timeframe: Follow-up phase - Week 20
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 24 (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 8 (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 1 (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 11 (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 16 (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 2 (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 24 (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 28 (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 3 (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 4 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 4 (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 5 (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 8 (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 3 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 12 (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 16 (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 24 (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 28 (NCT02818582)
Timeframe: Follow-up phase - Week 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 8 (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 1 (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 11 (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 16 (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 2 (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 24 (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 28 (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 3 (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 4 (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 5 (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 8 (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 12 (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 16 (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 20 (NCT02818582)
Timeframe: Follow-up phase - Week 20
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 24 (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 8 (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 1 (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 11 (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 16 (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 2 (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 24 (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 28 (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 3 (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 4 (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 5 (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 8 (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 12 (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 1 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 16 (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 2 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 24 (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 28 (NCT02818582)
Timeframe: Follow-up phase - Week 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 8 (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 1 (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 11 (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 16 (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 2 (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 24 (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 28 (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 3 (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 4 (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 5 (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 8 (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 12 (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 16 (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 20 (NCT02818582)
Timeframe: Follow-up phase - Week 20
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 24 (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 8 (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 1 (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 11 (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 16 (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 2 (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 24 (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 28 (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 3 (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 4 (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 5 (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 8 (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 12 (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 16 (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 24 (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 28 (NCT02818582)
Timeframe: Follow-up phase - Week 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 8 (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine aminotransferase (ALT) level at week 12 (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 1 (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 11 (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 16 (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 2 (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 24 (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 28 (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 3 (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 4 (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 5 (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at day 8 (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 16 (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 20 (NCT02818582)
Timeframe: Follow-up phase - Week 20
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 24 (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 1 |
Participants with grade 4 (> 10 x ULN) alanine transaminase (ALT) level at week 8 (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 1 (NCT02818582)
Timeframe: Treatment phase - Day 1
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 11 (NCT02818582)
Timeframe: Treatment phase - Day 11
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 16 (NCT02818582)
Timeframe: Treatment phase - Day 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 2 (NCT02818582)
Timeframe: Treatment phase - Day 2
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 3 (NCT02818582)
Timeframe: Treatment phase - Day 3
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 4 (NCT02818582)
Timeframe: Treatment phase - Day 4
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 5 (NCT02818582)
Timeframe: Treatment phase - Day 5
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 8 (NCT02818582)
Timeframe: Treatment phase - Day 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Participants with grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 28 (NCT02818582)
Timeframe: Follow-up phase - Week 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 24 (NCT02818582)
Timeframe: Treatment phase - Day 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at day 28 (NCT02818582)
Timeframe: Treatment phase - Day 28
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 12 (NCT02818582)
Timeframe: Follow-up phase - Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 16 (NCT02818582)
Timeframe: Follow-up phase - Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 24 (NCT02818582)
Timeframe: Follow-up phase - Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
Proportion of grade 4 (> 10 x ULN) aspartate transaminase (AST) level at week 8 (NCT02818582)
Timeframe: Follow-up phase - Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0 |
| Normal Saline Given Intravenously Daily for 5 Days | 0 |
6 reviews available for alanine and Hemorrhagic Fever, Ebola
| Article | Year |
|---|---|
Ebola.
Topics: Adenosine Monophosphate; Alanine; Animals; Antibodies, Monoclonal; Antibodies, Monoclonal, Murine-De | 2020 |
Remdesivir against COVID-19 and Other Viral Diseases.
Topics: Adenosine Monophosphate; Alanine; Antiviral Agents; Betacoronavirus; Clinical Trials as Topic; Compa | 2020 |
Remdesivir: A beacon of hope from Ebola virus disease to COVID-19.
Topics: Adenosine Monophosphate; Alanine; Antiviral Agents; Clinical Trials as Topic; COVID-19; COVID-19 Dru | 2020 |
Remdesivir: From Ebola to COVID-19.
Topics: Adenosine Monophosphate; Alanine; Antiviral Agents; COVID-19 Drug Treatment; Drug Discovery; Hemorrh | 2021 |
Broad-Spectrum Antiviral Strategies and Nucleoside Analogues.
Topics: Adenosine Monophosphate; Alanine; Amides; Animals; Antiviral Agents; COVID-19 Drug Treatment; Hemorr | 2021 |
Will There Be a Cure for Ebola?
Topics: Adenine; Adenosine; Adenosine Monophosphate; Africa, Western; Alanine; Animals; Antiviral Agents; Di | 2017 |
3 trials available for alanine and Hemorrhagic Fever, Ebola
| Article | Year |
|---|---|
A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.
Topics: Adenosine Monophosphate; Adolescent; Adult; Alanine; Antibodies, Monoclonal; Antiviral Agents; Child | 2019 |
A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.
Topics: Adenosine Monophosphate; Adolescent; Adult; Alanine; Antibodies, Monoclonal; Antiviral Agents; Child | 2019 |
A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.
Topics: Adenosine Monophosphate; Adolescent; Adult; Alanine; Antibodies, Monoclonal; Antiviral Agents; Child | 2019 |
A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.
Topics: Adenosine Monophosphate; Adolescent; Adult; Alanine; Antibodies, Monoclonal; Antiviral Agents; Child | 2019 |
A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.
Topics: Adenosine Monophosphate; Adolescent; Adult; Alanine; Antibodies, Monoclonal; Antiviral Agents; Child | 2019 |
A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.
Topics: Adenosine Monophosphate; Adolescent; Adult; Alanine; Antibodies, Monoclonal; Antiviral Agents; Child | 2019 |
A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.
Topics: Adenosine Monophosphate; Adolescent; Adult; Alanine; Antibodies, Monoclonal; Antiviral Agents; Child | 2019 |
A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.
Topics: Adenosine Monophosphate; Adolescent; Adult; Alanine; Antibodies, Monoclonal; Antiviral Agents; Child | 2019 |
A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics.
Topics: Adenosine Monophosphate; Adolescent; Adult; Alanine; Antibodies, Monoclonal; Antiviral Agents; Child | 2019 |
PREVAIL IV: A Randomized, Double-Blind, 2-Phase, Phase 2 Trial of Remdesivir vs Placebo for Reduction of Ebola Virus RNA in the Semen of Male Survivors.
Topics: Adenosine Monophosphate; Alanine; Double-Blind Method; Ebolavirus; Female; Follow-Up Studies; Hemorr | 2021 |
Randomised controlled trial begins for Ebola therapeutics.
Topics: Adenosine Monophosphate; Alanine; Antibodies, Monoclonal; Child, Preschool; Democratic Republic of t | 2018 |
17 other studies available for alanine and Hemorrhagic Fever, Ebola
| Article | Year |
|---|---|
Remdesivir is efficacious in rhesus monkeys exposed to aerosolized Ebola virus.
Topics: Adenosine Monophosphate; Administration, Intravenous; Aerosols; Alanine; Animals; Antiviral Agents; | 2021 |
[Remdesivir for COVID-19].
Topics: Adenosine Monophosphate; Alanine; Animals; Antiviral Agents; COVID-19 Drug Treatment; Hemorrhagic Fe | 2022 |
Combination therapy with remdesivir and monoclonal antibodies protects nonhuman primates against advanced Sudan virus disease.
Topics: Adenosine Monophosphate; Alanine; Animals; Antibodies, Monoclonal; Antibodies, Viral; Ebolavirus; He | 2022 |
A drug-disease model for predicting survival in an Ebola outbreak.
Topics: Alanine; Animals; Antibodies, Monoclonal; Antiviral Agents; Aspartate Aminotransferases; Creatinine; | 2022 |
Expanded profiling of Remdesivir as a broad-spectrum antiviral and low potential for interaction with other medications in vitro.
Topics: Adenosine Monophosphate; Alanine; Antiviral Agents; Filoviridae; Hemorrhagic Fever, Ebola; Humans; Z | 2023 |
New treatments for Ebola virus disease.
Topics: Adenosine Monophosphate; Alanine; Antibodies, Monoclonal; Antiviral Agents; Blood-Brain Barrier; Dem | 2019 |
Development and validation of a UHPLC-MS/MS method for quantification of the prodrug remdesivir and its metabolite GS-441524: a tool for clinical pharmacokinetics of SARS-CoV-2/COVID-19 and Ebola virus disease.
Topics: Adenosine Monophosphate; Adenosine Triphosphate; Alanine; Betacoronavirus; Chromatography, High Pres | 2020 |
Missed Opportunities on Emergency Remdesivir Use.
Topics: Adenosine Monophosphate; Alanine; Antiviral Agents; Betacoronavirus; Clinical Trials, Phase III as T | 2020 |
Why Remdesivir Failed: Preclinical Assumptions Overestimate the Clinical Efficacy of Remdesivir for COVID-19 and Ebola.
Topics: Adenosine Monophosphate; Alanine; Animals; Antiviral Agents; COVID-19 Drug Treatment; Hemorrhagic Fe | 2021 |
Novel quinolone derivatives targeting human dihydroorotate dehydrogenase suppress Ebola virus infection in vitro.
Topics: Adenosine Monophosphate; Africa, Western; Alanine; Antiviral Agents; Cell Line; Dihydroorotate Dehyd | 2021 |
Experimental drugs poised for use in Ebola outbreak.
Topics: Adenosine Monophosphate; Alanine; Amides; Antibodies, Monoclonal; Congo; Disease Outbreaks; Drugs, I | 2018 |
Public health round-up.
Topics: Adenosine Monophosphate; Alanine; Aminoisobutyric Acids; Anti-Bacterial Agents; Antibodies, Monoclon | 2019 |
In silico study of VP35 inhibitors: from computational alanine scanning to essential dynamics.
Topics: Alanine; Cell Line; Computer Simulation; Ebolavirus; Hemorrhagic Fever, Ebola; Humans; Ligands; Mole | 2015 |
Therapeutic efficacy of the small molecule GS-5734 against Ebola virus in rhesus monkeys.
Topics: Adenosine Monophosphate; Alanine; Amino Acid Sequence; Animals; Antiviral Agents; Cell Line, Tumor; | 2016 |
Late Ebola virus relapse causing meningoencephalitis: a case report.
Topics: Acute Disease; Adenosine Monophosphate; Adult; Alanine; Antiviral Agents; Cranial Nerve Diseases; Di | 2016 |
First Newborn Baby to Receive Experimental Therapies Survives Ebola Virus Disease.
Topics: Adenosine Monophosphate; Alanine; Antibodies, Monoclonal; Antiviral Agents; Blood; Female; Hemorrhag | 2017 |
Discovery and Synthesis of a Phosphoramidate Prodrug of a Pyrrolo[2,1-f][triazin-4-amino] Adenine C-Nucleoside (GS-5734) for the Treatment of Ebola and Emerging Viruses.
Topics: Adenosine Monophosphate; Alanine; Amides; Cell Line; Drug Discovery; Hemorrhagic Fever, Ebola; Human | 2017 |