adenine has been researched along with Adverse Drug Event in 52 studies
| Excerpt | Relevance | Reference |
|---|---|---|
| "Tenofovir disoproxil fumarate (TDF) has demonstrated long-term efficacy and a high barrier to resistance in multiple chronic hepatitis B (CHB) populations outside of China." | 9.20 | Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial. ( Chen, CW; Chen, SJ; Cheng, J; Dong, J; Gao, ZL; Hou, JL; Ji, Y; Jia, JD; Li, J; Mao, Q; Mao, YM; Ning, Q; Niu, JQ; Pan, C; Ren, H; Sheng, JF; Tan, DM; Tang, H; Wang, H; Wu, SM; Xie, Q; Xu, M; Zhang, JM; Zhang, XX; Zhao, W, 2015) |
| "Entecavir (ETV) plus adefovir (ADV) combination therapy may be a promising option for chronic hepatitis B (CHB) patients who have failed on prior nucleos(t)ide analog (NA) treatment." | 7.80 | Efficacy of 2years of entecavir plus adefovir therapy in patients with chronic hepatitis B who had failed on prior nucleos(t)ide analog treatment. ( Wang, X; Wang, Y; Xiong, Y; Zhang, C; Zhu, Y, 2014) |
| " The purpose of this study was to evaluate the effect of a new therapeutic strategy combining Lamivudine (LAM) and ADV in patients with HBeAg-positive chronic hepatitis B (CHB) and poor response to ADV monotherapy." | 7.76 | Combination of Lamivudine and adefovir therapy in HBeAg-positive chronic hepatitis B patients with poor response to adefovir monotherapy. ( Cao, J; Chen, EQ; Lei, BJ; Liu, L; Tang, H; Wang, JR; Wang, LC, 2010) |
| "Tenofovir disoproxil fumarate (TDF) has demonstrated long-term efficacy and a high barrier to resistance in multiple chronic hepatitis B (CHB) populations outside of China." | 5.20 | Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial. ( Chen, CW; Chen, SJ; Cheng, J; Dong, J; Gao, ZL; Hou, JL; Ji, Y; Jia, JD; Li, J; Mao, Q; Mao, YM; Ning, Q; Niu, JQ; Pan, C; Ren, H; Sheng, JF; Tan, DM; Tang, H; Wang, H; Wu, SM; Xie, Q; Xu, M; Zhang, JM; Zhang, XX; Zhao, W, 2015) |
| "Entecavir (ETV) plus adefovir (ADV) combination therapy may be a promising option for chronic hepatitis B (CHB) patients who have failed on prior nucleos(t)ide analog (NA) treatment." | 3.80 | Efficacy of 2years of entecavir plus adefovir therapy in patients with chronic hepatitis B who had failed on prior nucleos(t)ide analog treatment. ( Wang, X; Wang, Y; Xiong, Y; Zhang, C; Zhu, Y, 2014) |
| " We investigated the long-term safety and efficacy of these antiviral drugs in patients with chronic hepatitis B virus (HBV) infection, with compensated or decompensated cirrhosis, and compared results with those from lamivudine." | 3.79 | Long-term efficacy and safety of lamivudine, entecavir, and tenofovir for treatment of hepatitis B virus-related cirrhosis. ( Akbal, E; Akin, E; Alkan, E; Ataseven, H; Aygün, C; Başar, O; Baykal, O; Coban, S; Demir, M; Gülşen, MT; Ibiş, M; Koçkar, MC; Köklü, S; Köksal, AŞ; Küçükazman, M; Nadir, I; Ozdil, K; Pürnak, T; Tuna, Y; Yildirim, B; Yüksel, I; Yüksel, O, 2013) |
| " The purpose of this study was to evaluate the effect of a new therapeutic strategy combining Lamivudine (LAM) and ADV in patients with HBeAg-positive chronic hepatitis B (CHB) and poor response to ADV monotherapy." | 3.76 | Combination of Lamivudine and adefovir therapy in HBeAg-positive chronic hepatitis B patients with poor response to adefovir monotherapy. ( Cao, J; Chen, EQ; Lei, BJ; Liu, L; Tang, H; Wang, JR; Wang, LC, 2010) |
| " No subjects discontinued study drug because of an adverse event in the 48 weeks of randomized phase." | 2.80 | A randomized, open-label study of the safety and efficacy of switching stavudine or zidovudine to tenofovir disoproxil fumarate in HIV-1-infected children with virologic suppression. ( Arterburn, S; Castaño, E; Cheng, AK; Chuck, SL; Church, J; Deville, J; Enejosa, JV; Estripeaut, D; Gaur, A; Rathore, M; Rhee, MS; Saez-Llorens, X; White, K, 2015) |
| " We compared rates of upper digestive serious adverse events (sAEs) between TDF/FTC+EFV and TDF/FTC+ZDV patients during the first six months of treatment." | 2.78 | Early upper digestive tract side effects of zidovudine with tenofovir plus emtricitabine in West African adults with high CD4 counts. ( Anglaret, X; Bohoussou, F; Carrou, JL; Danel, C; Eholie, SP; Gabillard, D; Konan, R; Moh, R; Ouattara, E; Peytavin, G, 2013) |
| " Although frequency of severe renal toxicity was higher than has been reported in the literature, it was safe in patients with no comorbid renal conditions." | 2.73 | Effectiveness and safety of generic fixed-dose combination of tenofovir/emtricitabine/efavirenz in HIV-1-infected patients in Western India. ( Bele, V; Dravid, A; Gupte, N; Joshi, K; Pujari, S, 2008) |
| "The occurrence of adverse events was revealed as a major cause of ibrutinib failure in the real-world." | 2.72 | Keeping a balance in chronic lymphocytic leukemia (CLL) patients taking ibrutinib: ibrutinib-associated adverse events and their management based on drug interactions. ( Baek, DW; Cho, HJ; Kim, J; Lee, JM; Moon, JH; Sohn, SK, 2021) |
| " A pharmacokinetic study in healthy volunteers was conducted to assess the potential for a drug interaction between these agents." | 2.72 | Pharmacokinetics and safety of tenofovir disoproxil fumarate on coadministration with lopinavir/ritonavir. ( Cheng, AK; Ebrahimi, R; Kearney, BP; Mathias, A; Mittan, A; Sayre, J, 2006) |
| " Here side effects of ibrutinib have been summarized and important considerations in the management of these adverse events have been reviewed." | 2.61 | Management of adverse effects/toxicity of ibrutinib. ( Paydas, S, 2019) |
| "Long-term treatment of chronic hepatitis B (CHB) with nucleos(t)ide analogues is often necessary to achieve durable viral suppression." | 2.58 | Long-term safety and efficacy of nucleo(t)side analogue therapy in hepatitis B. ( Buti, M; Esteban, R; Riveiro-Barciela, M, 2018) |
| " A dosing regimen according to body-weight-band has been established for pediatric use." | 2.52 | Review of tenofovir use in HIV-infected children. ( Aurpibul, L; Puthanakit, T, 2015) |
| " Optimal PrEP agents and dosing regimens now need to be identified." | 2.48 | Considerations regarding antiretroviral chemoprophylaxis in MSM. ( Grulich, AE; Poynten, IM; Zablotska, I, 2012) |
| "There are limited data on treatment patterns, adverse events (AEs), and economic burden in younger, commercially insured patients treated for mantle cell lymphoma (MCL)." | 1.51 | Treatment patterns, adverse events, healthcare resource use and costs among commercially insured patients with mantle cell lymphoma in the United States. ( Burudpakdee, C; Kabadi, SM; Near, A; Wada, K, 2019) |
| "We conducted a retrospective analysis of chronic lymphocytic leukemia patients treated with ibrutinib either commercially or on clinical trials." | 1.48 | Toxicities and outcomes of 616 ibrutinib-treated patients in the United States: a real-world analysis. ( Bachow, SH; Barr, P; Brander, DM; Cheson, BD; Claxton, D; Dorsey, C; Goy, A; Hill, B; Howlett, C; Isaac, K; Kennard, KH; Kiselev, P; Lamanna, N; Landsburg, D; Mato, AR; Nabhan, C; Nasta, SD; Pu, J; Schuster, SJ; Skarbnik, A; Svoboda, J; Thompson, MC; Timlin, C; Ujjani, CS; Winter, A; Zent, C, 2018) |
| "Most patients with chronic lymphocytic leukemia (CLL) present with multiple comorbidities." | 1.48 | Comorbidities predict inferior outcomes in chronic lymphocytic leukemia treated with ibrutinib. ( Alqahtani, H; Amrock, SM; Choi, M; Churnetski, M; Cohen, JB; Danilov, AV; Gordon, MJ; Hoff, S; James, S; Kittai, A; Manda, S; Persky, D; Rivera, X; Spurgeon, SE, 2018) |
| "Due to the differences between bioavailability of efavirenz (EFV) and tenofovir (TDF), the single-tablet regimen of EFV/emtricitabine (FTC)/TDF is not approved as initial antiretroviral therapy (ART) in Europe by the European Medical Agency." | 1.42 | Safety and efficacy of coformulated efavirenz/emtricitabine/tenofovir single-tablet regimen in treatment-naive patients infected with HIV-1. ( De Castro, N; Delaugerre, C; Flandre, P; Gallien, S; Molina, JM; Nguyen, N, 2015) |
| " No serious adverse event related to tenofovir." | 1.42 | Efficacy, safety and pharmacokinetics of tenofovir disoproxil fumarate in virologic-suppressed HIV-infected children using weight-band dosing. ( Aurpibul, L; Chokephaibulkit, K; Cressey, TR; Phongsamart, W; Sirisanthana, V; Sricharoenchai, S; Sudjaritruk, T; Wittawatmongkol, O, 2015) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 1 (1.92) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 8 (15.38) | 29.6817 |
| 2010's | 38 (73.08) | 24.3611 |
| 2020's | 5 (9.62) | 2.80 |
| Authors | Studies |
|---|---|
| Alavian, G | 1 |
| Abbasian, L | 1 |
| Khalili, H | 1 |
| Alinaghi, SAS | 1 |
| Hasannezhad, M | 1 |
| Ashtiani, MF | 1 |
| Manshadi, SAD | 1 |
| Kabadi, SM | 1 |
| Near, A | 1 |
| Wada, K | 1 |
| Burudpakdee, C | 1 |
| Lasica, M | 1 |
| Tam, CS | 1 |
| Mehraban Far, P | 1 |
| Rullo, J | 1 |
| Farmer, J | 1 |
| Urton, T | 1 |
| Krause, O | 1 |
| Friedrichs, J | 1 |
| Heck, J | 1 |
| Cho, HJ | 1 |
| Baek, DW | 1 |
| Kim, J | 1 |
| Lee, JM | 1 |
| Moon, JH | 1 |
| Sohn, SK | 1 |
| de Weerdt, I | 1 |
| Koopmans, SM | 1 |
| Kater, AP | 1 |
| van Gelder, M | 1 |
| Mato, AR | 1 |
| Nabhan, C | 1 |
| Thompson, MC | 1 |
| Lamanna, N | 1 |
| Brander, DM | 1 |
| Hill, B | 1 |
| Howlett, C | 1 |
| Skarbnik, A | 1 |
| Cheson, BD | 1 |
| Zent, C | 1 |
| Pu, J | 1 |
| Kiselev, P | 1 |
| Goy, A | 1 |
| Claxton, D | 1 |
| Isaac, K | 1 |
| Kennard, KH | 1 |
| Timlin, C | 1 |
| Landsburg, D | 1 |
| Winter, A | 1 |
| Nasta, SD | 1 |
| Bachow, SH | 1 |
| Schuster, SJ | 1 |
| Dorsey, C | 1 |
| Svoboda, J | 1 |
| Barr, P | 1 |
| Ujjani, CS | 1 |
| Buti, M | 1 |
| Riveiro-Barciela, M | 1 |
| Esteban, R | 1 |
| Hodder, S | 1 |
| Squires, K | 1 |
| Kityo, C | 1 |
| Hagins, D | 1 |
| Avihingsanon, A | 1 |
| Kido, A | 1 |
| Jiang, S | 1 |
| Kulkarni, R | 1 |
| Cheng, A | 1 |
| Cao, H | 1 |
| Zou, L | 1 |
| Stecula, A | 1 |
| Gupta, A | 1 |
| Prasad, B | 1 |
| Chien, HC | 1 |
| Yee, SW | 1 |
| Wang, L | 1 |
| Unadkat, JD | 1 |
| Stahl, SH | 1 |
| Fenner, KS | 1 |
| Giacomini, KM | 1 |
| Gordon, MJ | 1 |
| Churnetski, M | 1 |
| Alqahtani, H | 1 |
| Rivera, X | 1 |
| Kittai, A | 1 |
| Amrock, SM | 1 |
| James, S | 1 |
| Hoff, S | 1 |
| Manda, S | 1 |
| Spurgeon, SE | 1 |
| Choi, M | 1 |
| Cohen, JB | 1 |
| Persky, D | 1 |
| Danilov, AV | 1 |
| Paydas, S | 1 |
| Shafran, SD | 1 |
| Di Perri, G | 2 |
| Esser, S | 1 |
| Lelièvre, JD | 1 |
| Parczewski, M | 1 |
| Frustaci, AM | 1 |
| Tedeschi, A | 1 |
| Deodato, M | 1 |
| Zamprogna, G | 1 |
| Cairoli, R | 1 |
| Montillo, M | 1 |
| Ouattara, E | 1 |
| Danel, C | 1 |
| Moh, R | 1 |
| Gabillard, D | 1 |
| Peytavin, G | 1 |
| Konan, R | 1 |
| Carrou, JL | 1 |
| Bohoussou, F | 1 |
| Eholie, SP | 1 |
| Anglaret, X | 1 |
| Njuguna, C | 1 |
| Orrell, C | 1 |
| Kaplan, R | 1 |
| Bekker, LG | 1 |
| Wood, R | 1 |
| Lawn, SD | 1 |
| Zoungrana, J | 1 |
| Hema, A | 1 |
| Bado, G | 1 |
| Poda, GE | 1 |
| Kamboulé, EB | 1 |
| Kaboré, FN | 1 |
| Soré, I | 1 |
| Sawadogo, AB | 1 |
| Wang, X | 1 |
| Zhang, C | 1 |
| Zhu, Y | 1 |
| Xiong, Y | 1 |
| Wang, Y | 1 |
| Gallien, S | 1 |
| Flandre, P | 1 |
| Nguyen, N | 1 |
| De Castro, N | 1 |
| Molina, JM | 1 |
| Delaugerre, C | 1 |
| Shankar, GN | 1 |
| Alt, C | 1 |
| Hou, JL | 1 |
| Gao, ZL | 1 |
| Xie, Q | 1 |
| Zhang, JM | 1 |
| Sheng, JF | 1 |
| Cheng, J | 1 |
| Chen, CW | 1 |
| Mao, Q | 1 |
| Zhao, W | 1 |
| Ren, H | 1 |
| Tan, DM | 1 |
| Niu, JQ | 1 |
| Chen, SJ | 1 |
| Pan, C | 1 |
| Tang, H | 2 |
| Wang, H | 1 |
| Mao, YM | 1 |
| Jia, JD | 1 |
| Ning, Q | 1 |
| Xu, M | 1 |
| Wu, SM | 1 |
| Li, J | 2 |
| Zhang, XX | 1 |
| Ji, Y | 1 |
| Dong, J | 1 |
| Aurpibul, L | 2 |
| Puthanakit, T | 1 |
| Maggi, P | 1 |
| Montinaro, V | 1 |
| Leone, A | 1 |
| Fasano, M | 1 |
| Volpe, A | 1 |
| Bellacosa, C | 1 |
| Grattagliano, V | 1 |
| Coladonato, L | 1 |
| Lapadula, G | 1 |
| Santantonio, T | 1 |
| Angarano, G | 1 |
| Havens, PL | 1 |
| Hazra, R | 1 |
| Della Negra, M | 1 |
| De Carvalho, AP | 1 |
| De Aquino, MZ | 1 |
| Pinto, JA | 1 |
| Da Silva, MT | 1 |
| Andreatta, KN | 1 |
| Graham, B | 1 |
| Liu, YP | 1 |
| Quirk, EK | 1 |
| Cressey, TR | 1 |
| Sricharoenchai, S | 1 |
| Wittawatmongkol, O | 1 |
| Sirisanthana, V | 1 |
| Phongsamart, W | 1 |
| Sudjaritruk, T | 1 |
| Chokephaibulkit, K | 1 |
| Saez-Llorens, X | 1 |
| Castaño, E | 1 |
| Rathore, M | 1 |
| Church, J | 1 |
| Deville, J | 1 |
| Gaur, A | 1 |
| Estripeaut, D | 1 |
| White, K | 1 |
| Arterburn, S | 1 |
| Enejosa, JV | 1 |
| Cheng, AK | 2 |
| Chuck, SL | 1 |
| Rhee, MS | 1 |
| Langerbeins, P | 1 |
| Bahlo, J | 1 |
| Rhein, C | 1 |
| Cramer, P | 1 |
| Pflug, N | 1 |
| Fischer, K | 1 |
| Stilgenbauer, S | 1 |
| Kreuzer, KA | 1 |
| Wendtner, CM | 1 |
| Eichhorst, B | 1 |
| Hallek, M | 1 |
| Freitas, EO | 1 |
| Nico, D | 1 |
| Alves-Silva, MV | 1 |
| Morrot, A | 1 |
| Clinch, K | 1 |
| Evans, GB | 1 |
| Tyler, PC | 1 |
| Schramm, VL | 1 |
| Palatnik-de-Sousa, CB | 1 |
| Antela, A | 1 |
| Aguiar, C | 1 |
| Compston, J | 1 |
| Hendry, BM | 1 |
| Boffito, M | 1 |
| Mallon, P | 1 |
| Pourcher-Martinez, V | 1 |
| Gazzard, B | 1 |
| Jain, P | 1 |
| Thompson, PA | 1 |
| Keating, M | 1 |
| Estrov, Z | 1 |
| Ferrajoli, A | 1 |
| Jain, N | 1 |
| Kantarjian, H | 1 |
| Burger, JA | 1 |
| O'Brien, S | 1 |
| Wierda, WG | 1 |
| Libório, AB | 1 |
| Andrade, L | 1 |
| Pereira, LV | 1 |
| Sanches, TR | 1 |
| Shimizu, MH | 1 |
| Seguro, AC | 1 |
| Pujari, S | 1 |
| Dravid, A | 1 |
| Gupte, N | 1 |
| Joshi, K | 1 |
| Bele, V | 1 |
| Wang, LC | 1 |
| Chen, EQ | 1 |
| Cao, J | 1 |
| Liu, L | 1 |
| Wang, JR | 1 |
| Lei, BJ | 1 |
| Martin, A | 1 |
| Bloch, M | 1 |
| Amin, J | 1 |
| Baker, D | 1 |
| Cooper, DA | 1 |
| Emery, S | 1 |
| Carr, A | 1 |
| Reiss, P | 1 |
| Hosseinipour, MC | 1 |
| Kumwenda, JJ | 1 |
| Weigel, R | 1 |
| Brown, LB | 1 |
| Mzinganjira, D | 1 |
| Mhango, B | 1 |
| Eron, JJ | 1 |
| Phiri, S | 1 |
| van Oosterhout, JJ | 1 |
| Ishii, Y | 1 |
| Nurrochmad, A | 1 |
| Yamada, H | 1 |
| Kauf, TL | 1 |
| Farkouh, RA | 1 |
| Earnshaw, SR | 1 |
| Watson, ME | 1 |
| Maroudas, P | 1 |
| Chambers, MG | 1 |
| Keller, MJ | 1 |
| Madan, RP | 1 |
| Torres, NM | 1 |
| Fazzari, MJ | 1 |
| Cho, S | 1 |
| Kalyoussef, S | 1 |
| Shust, G | 1 |
| Mesquita, PM | 1 |
| Louissaint, N | 1 |
| Chen, J | 1 |
| Cohen, HW | 1 |
| Diament, EC | 1 |
| Lee, AC | 1 |
| Soto-Torres, L | 1 |
| Hendrix, CW | 1 |
| Herold, BC | 1 |
| Lampiris, HW | 1 |
| Eluwa, GI | 1 |
| Badru, T | 1 |
| Agu, KA | 1 |
| Akpoigbe, KJ | 1 |
| Chabikuli, O | 1 |
| Hamelmann, C | 1 |
| Poynten, IM | 1 |
| Zablotska, I | 1 |
| Grulich, AE | 1 |
| McGowan, I | 1 |
| Köklü, S | 1 |
| Tuna, Y | 1 |
| Gülşen, MT | 1 |
| Demir, M | 1 |
| Köksal, AŞ | 1 |
| Koçkar, MC | 1 |
| Aygün, C | 1 |
| Coban, S | 1 |
| Ozdil, K | 1 |
| Ataseven, H | 2 |
| Akin, E | 1 |
| Pürnak, T | 1 |
| Yüksel, I | 1 |
| Ibiş, M | 1 |
| Yildirim, B | 1 |
| Nadir, I | 1 |
| Küçükazman, M | 1 |
| Akbal, E | 1 |
| Yüksel, O | 1 |
| Başar, O | 1 |
| Alkan, E | 1 |
| Baykal, O | 1 |
| Hussar, DA | 1 |
| PAOLINO, W | 1 |
| VERCELLINO, E | 1 |
| Padmanabhan, S | 1 |
| Coughlin, JE | 1 |
| Zhang, G | 1 |
| Kirk, CJ | 1 |
| Iyer, RP | 1 |
| Kearney, BP | 1 |
| Mathias, A | 1 |
| Mittan, A | 1 |
| Sayre, J | 1 |
| Ebrahimi, R | 1 |
| Gröbner, W | 1 |
| Walter-Sack, I | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Treatment Patterns, Outcomes, and Patient-Reported Health-Related Quality of Life: A Prospective Disease Registry of Patients With Mantle Cell Lymphoma Treated With Novel Agents[NCT03816683] | 229 participants (Actual) | Observational | 2019-04-01 | Active, not recruiting | |||
| Benefits and Risks of Early Antiretroviral Therapy in HIV-infected Adults in Abidjan, Côte d'Ivoire: Randomized Controlled Trial (ANRS 12136 TEMPRANO)[NCT00495651] | Phase 3 | 2,073 participants (Actual) | Interventional | 2008-03-31 | Completed | ||
| Combination Treatment of Nucleoside （Acid）Analogue (NAs) and Pegylated Interferon α-2b for NAs Treated, Hepatitis B Related, Compensatory Cirrhosis Patients With Low Level Hepatitis b Virus Surface Antigen (HBsAg)[NCT03969017] | Phase 2 | 84 participants (Anticipated) | Interventional | 2019-06-17 | Recruiting | ||
| A Multi-centre, Double Blind, Double Dummy, Randomised, Controlled Study to Evaluate the Efficacy and Safety of TDF 300mg Once Daily (QD) Versus Adefovir Dipivoxil (ADV) 10mg QD in Chinese Subjects With CHB[NCT01300234] | Phase 3 | 512 participants (Actual) | Interventional | 2011-03-30 | Completed | ||
| A Phase III, Randomized, Open-Label Study Comparing the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate Versus Continuing Stavudine or Zidovudine in Virologically Suppressed HIV-Infected Children Taking Highly Act[NCT00528957] | Phase 3 | 97 participants (Actual) | Interventional | 2006-12-28 | Completed | ||
| Phase III Randomized Study to Investigate the Use of Acalabrutinib in the Treatment of Patients With Early Stage CLL With High Risk of Early Disease Progression[NCT04178798] | Phase 3 | 22 participants (Actual) | Interventional | 2019-12-09 | Active, not recruiting | ||
| The Effects of Vitamin D and Calcium Supplementation to Parathyroid Hormone in CHB Patients Treated With Tenofovir Disoproxil Fumarate[NCT05313477] | Phase 4 | 64 participants (Anticipated) | Interventional | 2022-05-01 | Recruiting | ||
| A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study.[NCT00192634] | Phase 4 | 357 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
| Effect of Repeated Applications of Tenofovir Gel on Mucosal Mediators of Immunity and Intrinsic Antimicrobial Activity of Cervicovaginal Secretions in Women at Low Risk for HIV-1 Infection[NCT00594373] | Phase 1 | 30 participants (Actual) | Interventional | Completed | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
"Change from Baseline of log 10 copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 in the HBeAg-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually a negative result indicates that the participant has lower levels of virus in the blood and less infectious. Values at Day 0 were considered as Baseline values. Change from Baseline was calculated as post Baseline values minus Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed." (NCT01300234)
Timeframe: Baseline, Weeks 48, 96, 144, 192 and 240
| Intervention | log10 copies/mL (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 48,HBeAg-positive, n=102, 97 | Week 48,HBeAg-negative, n=151, 148 | Week 96, HBeAg-positive, n=101, 97 | Week 96, HBeAg-negative, n=147,148 | Week 144, HBeAg-postive, n=100, 96 | Week 144, HBeAg-negative, n=145, 146 | Week 192, HBeAg-positive, n=97,93 | Week 192, HBeAg-negative, n=145,145 | Week 240, HBeAg-positive, n=91,90 | Week 240, HBeAg-negative, n=138,138 | |
| ADV-TDF | -4.4 | -4.3 | -6.5 | -4.8 | -6.5 | -4.9 | -6.6 | -4.8 | -6.5 | -4.9 |
| TDF-TDF | -6.4 | -4.9 | -6.5 | -4.9 | -6.6 | -4.9 | -6.6 | -4.9 | -6.6 | -4.9 |
HBsAg loss is defined as a negative HBsAg result for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240. (NCT01300234)
Timeframe: Weeks 24, 48, 96, 144, 192 and 240
| Intervention | Participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 24, HBsAg loss | Week 24, HBsAg seroconversion | Week 48, HBsAg loss | Week 48, HBsAg seroconversion | Week 96, HBsAg loss | Week 96, HBsAg seroconversion | Week 144, HBsAg loss | Week 144, HBsAg seroconversion | Week 192, HBsAg loss | Week 192, HBsAg seroconversion | Week 240, HBsAg loss | Week 240, HBsAg seroconversion | |
| ADV-TDF | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| TDF-TDF | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
HBeAg loss is defined as a negative HBeAg result for those participants who were HBeAg positive at Baseline. Seroconversion to anti-HBe is defined as HBeAg loss and a positive anti-HBe result. This report includes data up to and including Weeks 24, 48, 96, 144, 192 and 240. (NCT01300234)
Timeframe: Weeks 24, 48, 96, 144, 192 and 240
| Intervention | Participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 24, HBeAg loss | Week 24, HBeAg seroconversion | Week 48, HBeAg loss | Week 48, HBeAg seroconversion | Week 96, HBeAg loss | Week 96, HBeAg seroconversion | Week 144, HBeAg loss | Week 144, HBeAg seroconversion | Week 192, HBeAg loss | Week 192, HBeAg seroconversion | Week 240, HBeAg loss | Week 240, HBeAg seroconversion | |
| ADV-TDF | 4 | 4 | 10 | 9 | 21 | 18 | 24 | 20 | 31 | 24 | 36 | 28 |
| TDF-TDF | 15 | 14 | 18 | 16 | 37 | 32 | 37 | 33 | 43 | 33 | 43 | 33 |
HBsAg loss is defined as negative HBsAg results for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240. (NCT01300234)
Timeframe: Weeks 24, 48, 96, 144, 192 and 240
| Intervention | Participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 24, HBsAg loss | Week 24, HBsAg seroconversion | Week 48, HBsAg loss | Week 48, HBsAg seroconversion | Week 96, HBsAg loss | Week 96, HBsAg seroconversion | Week 144, HBsAg loss | Week 144, HBaAg seroconversion | Week 192, HBsAg, loss | Week 192, HBsAg, seroconversion | Week 240, HBsAg loss | Week 240 HBsAg seroconversion | |
| ADV-TDF | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| TDF-TDF | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 |
"Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart. This report includes data up to and including Week 48. A non-completers equal failures approach was used for the analysis in ITT population." (NCT01300234)
Timeframe: Week 24 to Week 48
| Intervention | Participants (Number) | |
|---|---|---|
| HBeAg-positive, n =100, 97 | HBeAg-negative, n=150, 147 | |
| ADV 10 mg | 0 | 0 |
| TDF 300 mg | 0 | 0 |
"Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart from Week 96 to 240. This report includes data up to and including Week 240. A non-completers equal failures approach was used for the analysis in ITT population." (NCT01300234)
Timeframe: Week 96 to Week 240
| Intervention | Participants (Number) | |
|---|---|---|
| HBeAg-positive, n= 88, 90 | HBeAg-negative, n = 132, 137 | |
| ADV-TDF | 0 | 1 |
| TDF-TDF | 1 | 0 |
"The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was used for grading. Confirmed is defined as two consecutive visits. mg=milligrams. dL=deciliter, G= Grade." (NCT01300234)
Timeframe: Up to Week 240
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Creatinine increase of 0.5 mg/dL above Baseline | Confirmed creatinine >=2.0 mg/dL | Confirmed clearance <50 milliliters/minute | Confirmed phosphorus G 3/4 abnormality, <2.0 mg/dL | |
| ADV-TDF | 0 | 0 | 0 | 0 |
| TDF-TDF | 1 | 0 | 0 | 3 |
"Participants who had abnormal ALT at Baseline and had normalized ALT at Weeks 48, 96, 144, 192 and 240 were assessed. This report includes data up to and including Weeks 48, 96, 144, 192 and 240. An increased level of ALT is referred to as abnormal ALT (the normal range is 0 to 48 units per liter [U/L]). Values at Day 0 were considered as Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed." (NCT01300234)
Timeframe: Baseline; Weeks 48, 96, 144, 192 and 240
| Intervention | Participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 48, HBeAg-positive, n=102, 97 | Week 48, HBeAg-negative, n=136, 132 | Week 96, HBeAg-positive, n=102, 97 | Week 96, HBeAg-negative, n=136,132 | Week 144, HBeAg-positive, n=102, 97 | Week 144, HBeAg-negative, n=136, 132 | Week 192, HBeAg-positive, n=102, 97 | Week 192, HBeAg-negative, n=136,132 | Week 240, HBeAg-positive, n=102, 97 | Week 240, HBeAg-negative, n=136,132 | |
| ADV-TDF | 83 | 116 | 88 | 118 | 87 | 119 | 79 | 118 | 80 | 111 |
| TDF-TDF | 88 | 120 | 93 | 126 | 92 | 123 | 89 | 125 | 82 | 119 |
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is Grade 4 (life threatening or disabling). Participants with any non-serious AEs and SAEs has been reported. (NCT01300234)
Timeframe: Up to Week 240 treatment period and 24 weeks follow-up visit off treatment
| Intervention | Participants (Number) | |
|---|---|---|
| Non-serious AE | SAE | |
| ADV-TDF | 121 | 20 |
| TDF-TDF | 140 | 12 |
Histological improvement is defined as a reduction of >=2 points in the KNS with no increase in fibrosis at Week 48 and Week 240 in participants with Baseline KNS >=2 which was derived from the American Association for the Study of Liver Diseases Practice Guidelines for Management of Chronic Hepatitis B (2009) and the European Association for the Study of the Liver Clinical Practice Guidelines Management of chronic hepatitis B virus infection (2012). The Knodell scale consists of 5 domains: periportal +/- bridging necrosis (scored from best to worst: 0, 1, 3, 4, 5, 6, or 10); intralobular degeneration and focal necrosis (0 to 4); portal inflammation (0 to 4); and fibrosis (0 to 4). The necroinflammatory score (ranging from 0 [best] to 14 [worst]) is the combined score for necrosis (0 to 10) plus inflammation (0 to 4; the participant is scored for only one inflammatory condition). Liver biopsy slides within 6 months prior to randomization could be accepted as Baseline evaluation. (NCT01300234)
Timeframe: Baseline; Week 48 and Week 240
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Week 48, HBeAg-positive, n=38, 49 | Week 48, HBeAg-negative, n=45, 50 | Week 240, HBeAg-positive, n=38, 49 | Week 240, HBeAg-negative, n=45, 50 | |
| ADV-TDF | 39 | 34 | 2 | 4 |
| TDF-TDF | 31 | 32 | 5 | 8 |
TE grade 3 or grade 4 LAs are defined as values that increase by >=1 grade from Baseline (Day 0) to Grade 3 (severe) or 4 (potentially life threatening) at any post-Baseline value. The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Laboratory parameters assessed included Sodium for hyponatremia and hypernatremia; Potassium for hypokalemia and hyperkalemia; glucose for hypoglycemia and hyperglycemia non-fasting; Phosphate for hypophosphatemia; alanine aminotransferase/aspartate aminotransferase, bilirubin, creatinine kinase, hemoglobin, platelets, neutrophils, lymphocytes, prothrombin time and amylase. (NCT01300234)
Timeframe: Up to Week 240
| Intervention | participants (Number) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sodium | Phosphate | Alanine aminotransferase | Aspartate aminotransferase | Bilirubin | Creatine kinase | Hemoglobin | Platelets | Neutrophils | Prothrombin time | Potassium | Glucose | Lymphocytes | Amylase | |
| ADV-TDF | 0 | 3 | 14 | 6 | 1 | 4 | 5 | 3 | 4 | 17 | 0 | 2 | 3 | 2 |
| TDF-TDF | 2 | 2 | 19 | 10 | 1 | 6 | 4 | 4 | 6 | 10 | 1 | 1 | 2 | 1 |
The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Serum creatinine: Grade 1, > 133 to 177 micromoles per Liter (µmoles/Liter), Grade 2, >177 to 265 µmoles/Liter, Grade 3, >265 to 530 µmoles/Liter, Grade 4, >530 µmoles/Liter. Serum phosphorus: Grade 2, 0.63 to <0.80 millimoles per Liter (mmoles/L), Grade 3, 0.31 to <0.63 mmoles/L, Grade 4, <0.31 mmoles/L. The normal range for serum phosphorus was 0.8 to 1.45 mmoles/L; the upper limit for a Grade 2 abnormality is 0.80 mmoles/L. Therefore, no Grade 1 abnormalities could be attributed, as values were contained within the normal range. NA indicates the value was not available for the indicated time point. (NCT01300234)
Timeframe: Up to Week 240
| Intervention | Participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Serum creatinine, Grade 1 | Serum creatinine, Grade 2 | Serum creatinine, Grade 3 | Serum creatinine, Grade 4 | Serum phosphorus, Grade 1 | Serum phosphorus, Grade 2 | Serum phosphorus, Grade 3 | Serum phosphorus, Grade 4 | |
| ADV-TDF | 1 | 0 | 0 | 0 | NA | 55 | 3 | 0 |
| TDF-TDF | 0 | 0 | 0 | 0 | NA | 42 | 2 | 0 |
"The number of HBeAg-positive and HBeAg-negative participants who had virological breakthrough at Weeks 48, 96, 144, 192 and 240 were assessed. Virological breakthrough is defined by >= one log increase in HBV DNA from NADIR (as determined by two sequential HBV DNA measurements at least one month apart or last on treatment measurement). A non-completers equal failures approach was used for the analysis in ITT population." (NCT01300234)
Timeframe: Weeks 48, 96, 144, 192 and 240
| Intervention | Participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 48,HBeAg-Positive, n=103, 99 | Week 48, HBeAg-Negative, n=154, 153 | Week 96, HBeAg-positive, n=103, 99 | Week 96, HBeAg-negative, n=154, 153 | Week 144, HBeAg-positive, n=103, 99 | Week 144, HBeAg-negative, n=154, 153 | Week 192, HBeAg-positive, n=103, 99 | Week 192, HBeAg-negative, n=154, 153 | Week 240, HBeAg-positive, n=103, 99 | Week 240, HBeAg-negative, n=154, 153 | |
| ADV-TDF | 4 | 2 | 4 | 3 | 7 | 4 | 7 | 5 | 11 | 8 |
| TDF-TDF | 0 | 0 | 0 | 2 | 0 | 3 | 0 | 3 | 4 | 3 |
"The number of participants with HBV DNA <400 copies/mL in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed." (NCT01300234)
Timeframe: Weeks 96, 144, 192, and 240
| Intervention | Participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 96, HBeAg-positive, n=103, 99 | Week 96, HBeAg-negative, n=154, 153 | Week 144, HBeAg-positive, n=103, 99 | Week 144, HBeAg-negative, n=154,153 | Week 192, HBeAg-positive, n=103,99 | Week 192,HBeAg-negative, n=154,153 | Week 240, HBeAg-positive, n=103,99 | Week 240, HBeAg-negative, n=154,153 | |
| ADV-TDF | 92 | 143 | 95 | 145 | 93 | 141 | 87 | 137 |
| TDF-TDF | 95 | 144 | 97 | 144 | 94 | 144 | 87 | 138 |
"The number of participants with Hepatitis B Virus (HBV) deoxyribonucleic acid (DNA) <400 copies/milliliter (mL) at Week 48 in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed." (NCT01300234)
Timeframe: Week 48
| Intervention | Participants (Number) | |
|---|---|---|
| HBeAg-positive, n=103, 99 | HBeAg-negative, n=154, 153 | |
| ADV 10 mg | 18 | 109 |
| TDF 300 mg | 79 | 149 |
This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 144 weeks
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Tenofovir DF | -139 |
| (Stavudine or Zidovudine)/TDF | -146 |
| All TDF | -142 |
This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 192 weeks
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Tenofovir DF | -304 |
| (Stavudine or Zidovudine)/TDF | -177 |
| All TDF | -233 |
This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 240 weeks
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Tenofovir DF | -369 |
| (Stavudine or Zidovudine)/TDF | -296 |
| All TDF | -329 |
This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 288 weeks
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Tenofovir DF | -346 |
| (Stavudine or Zidovudine)/TDF | -256 |
| All TDF | -302 |
This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 336 weeks
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Tenofovir DF | -415 |
| (Stavudine or Zidovudine)/TDF | -283 |
| All TDF | -350 |
This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 384 weeks
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Tenofovir DF | -620 |
| (Stavudine or Zidovudine)/TDF | -305 |
| All TDF | -512 |
This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 432 weeks
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Tenofovir DF | -795 |
| (Stavudine or Zidovudine)/TDF | -302 |
| All TDF | -631 |
This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug. (NCT00528957)
Timeframe: Baseline and 48 weeks
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Tenofovir DF | -97 |
| Stavudine or Zidovudine | -11 |
| All TDF | 2 |
This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 480 weeks
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Tenofovir DF | -923 |
| (Stavudine or Zidovudine)/TDF | -448 |
| All TDF | -813 |
This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 528 weeks
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Tenofovir DF | -710 |
| All TDF | -710 |
This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 96 weeks
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Tenofovir DF | -77 |
| (Stavudine or Zidovudine)/TDF | -56 |
| All TDF | -67 |
This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 144 weeks
| Intervention | percentage (Mean) |
|---|---|
| Tenofovir DF | 0.8 |
| (Stavudine or Zidovudine)/TDF | -0.1 |
| All TDF | 0.3 |
This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 192 weeks
| Intervention | percentage (Mean) |
|---|---|
| Tenofovir DF | 1.1 |
| (Stavudine or Zidovudine)/TDF | 0.6 |
| All TDF | 0.8 |
This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 240 weeks
| Intervention | percentage (Mean) |
|---|---|
| Tenofovir DF | 1.3 |
| (Stavudine or Zidovudine)/TDF | -0.9 |
| All TDF | 0.1 |
This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 288 weeks
| Intervention | percentage (Mean) |
|---|---|
| Tenofovir DF | 2.0 |
| (Stavudine or Zidovudine)/TDF | 0.5 |
| All TDF | 1.3 |
This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 336 weeks
| Intervention | percentage (Mean) |
|---|---|
| Tenofovir DF | 2.0 |
| (Stavudine or Zidovudine)/TDF | 0.8 |
| All TDF | 1.4 |
This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 384 weeks
| Intervention | percentage (Mean) |
|---|---|
| Tenofovir DF | 0.5 |
| (Stavudine or Zidovudine)/TDF | 1.6 |
| All TDF | 0.9 |
This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 432 weeks
| Intervention | percentage (Mean) |
|---|---|
| Tenofovir DF | 0.3 |
| (Stavudine or Zidovudine)/TDF | 2.9 |
| All TDF | 1.1 |
This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug. (NCT00528957)
Timeframe: Baseline and 48 weeks
| Intervention | percentage (Mean) |
|---|---|
| Tenofovir DF | 0.3 |
| Stavudine or Zidovudine | 1.1 |
| All TDF | 0.6 |
This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 480 weeks
| Intervention | percentage (Mean) |
|---|---|
| Tenofovir DF | 2.3 |
| (Stavudine or Zidovudine)/TDF | 5.0 |
| All TDF | 2.9 |
This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 528 weeks
| Intervention | percentage (Mean) |
|---|---|
| Tenofovir DF | 4.5 |
| All TDF | 4.5 |
This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 96 weeks
| Intervention | percentage (Mean) |
|---|---|
| Tenofovir DF | 1.3 |
| (Stavudine or Zidovudine)/TDF | -0.1 |
| All TDF | 0.6 |
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF. (NCT00528957)
Timeframe: 192 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 70.6 |
| (Stavudine or Zidovudine)/TDF | 82.5 |
| All TDF | 77.0 |
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF. (NCT00528957)
Timeframe: 240 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 70.6 |
| (Stavudine or Zidovudine)/TDF | 75.7 |
| All TDF | 73.2 |
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 288 weeks of exposure to TDF. (NCT00528957)
Timeframe: 288 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 81.5 |
| (Stavudine or Zidovudine)/TDF | 67.6 |
| All TDF | 73.4 |
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF. (NCT00528957)
Timeframe: 336 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 90.9 |
| (Stavudine or Zidovudine)/TDF | 100.0 |
| All TDF | 95.3 |
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF. (NCT00528957)
Timeframe: 384 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 100.0 |
| (Stavudine or Zidovudine)/TDF | 100.0 |
| All TDF | 100.0 |
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF. (NCT00528957)
Timeframe: 432 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 100.0 |
| (Stavudine or Zidovudine)/TDF | 85.7 |
| All TDF | 95.0 |
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF. (NCT00528957)
Timeframe: 480 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 88.9 |
| (Stavudine or Zidovudine)/TDF | 100.0 |
| All TDF | 90.9 |
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF. (NCT00528957)
Timeframe: 528 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 100.0 |
| All TDF | 100.0 |
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF. (NCT00528957)
Timeframe: 144 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 73.7 |
| (Stavudine or Zidovudine)/TDF | 87.5 |
| All TDF | 80.8 |
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug. (NCT00528957)
Timeframe: 48 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 83.3 |
| Stavudine or Zidovudine | 91.8 |
| All TDF | 85.4 |
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF. (NCT00528957)
Timeframe: 96 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 81.6 |
| (Stavudine or Zidovudine)/TDF | 85.4 |
| All TDF | 83.5 |
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF. (NCT00528957)
Timeframe: 144 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 63.2 |
| (Stavudine or Zidovudine)/TDF | 75.0 |
| All TDF | 69.2 |
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF. (NCT00528957)
Timeframe: 192 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 67.6 |
| (Stavudine or Zidovudine)/TDF | 75.0 |
| All TDF | 71.6 |
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF. (NCT00528957)
Timeframe: 240 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 70.6 |
| (Stavudine or Zidovudine)/TDF | 73.0 |
| All TDF | 71.8 |
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF. (NCT00528957)
Timeframe: 288 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 81.5 |
| (Stavudine or Zidovudine)/TDF | 62.2 |
| All TDF | 70.3 |
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF. (NCT00528957)
Timeframe: 336 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 86.4 |
| (Stavudine or Zidovudine)/TDF | 90.5 |
| All TDF | 88.4 |
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF. (NCT00528957)
Timeframe: 384 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 88.2 |
| (Stavudine or Zidovudine)/TDF | 100.0 |
| All TDF | 92.3 |
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF. (NCT00528957)
Timeframe: 432 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 100.0 |
| (Stavudine or Zidovudine)/TDF | 71.4 |
| All TDF | 90.0 |
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug. (NCT00528957)
Timeframe: 48 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 70.8 |
| Stavudine or Zidovudine | 85.7 |
| All TDF | 68.5 |
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF. (NCT00528957)
Timeframe: 480 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 77.8 |
| (Stavudine or Zidovudine)/TDF | 50.0 |
| All TDF | 72.7 |
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF. (NCT00528957)
Timeframe: 528 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 100.0 |
| All TDF | 100.0 |
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF. (NCT00528957)
Timeframe: 96 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 76.3 |
| (Stavudine or Zidovudine)/TDF | 68.3 |
| All TDF | 72.2 |
This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT00528957)
Timeframe: 48 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 88.6 |
| Stavudine or Zidovudine | 89.6 |
This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT00528957)
Timeframe: 48 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 75.0 |
| Stavudine or Zidovudine | 81.3 |
12 reviews available for adenine and Adverse Drug Event
| Article | Year |
|---|---|
Management of Ibrutinib Toxicities: a Practical Guide.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Antineoplastic Agents; Drug-Related Side Effects and A | 2020 |
Keeping a balance in chronic lymphocytic leukemia (CLL) patients taking ibrutinib: ibrutinib-associated adverse events and their management based on drug interactions.
Topics: Adenine; Aged; COVID-19; Disease Management; Drug Interactions; Drug-Related Side Effects and Advers | 2021 |
Incidence and management of toxicity associated with ibrutinib and idelalisib: a practical approach.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Antineoplastic Agents; Disease Management; Drug Intera | 2017 |
Long-term safety and efficacy of nucleo(t)side analogue therapy in hepatitis B.
Topics: Adenine; Administration, Oral; Alanine; Antiviral Agents; Drug-Related Side Effects and Adverse Reac | 2018 |
Management of adverse effects/toxicity of ibrutinib.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Atrial Fibrillation; Drug-Related Side Effects and Adv | 2019 |
Planning HIV therapy to prevent future comorbidities: patient years for tenofovir alafenamide.
Topics: Adenine; Age Factors; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Clinical Tria | 2019 |
Review of tenofovir use in HIV-infected children.
Topics: Adenine; Adolescent; Adult; Anti-HIV Agents; Bone and Bones; Child; Child, Preschool; Drug Utilizati | 2015 |
The role of tenofovir alafenamide in future HIV management.
Topics: Adenine; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Drug-Related Side Effects | 2016 |
Modulation of UDP-glucuronosyltransferase activity by endogenous compounds.
Topics: Acyl Coenzyme A; Adenine; Animals; Antigens; Drug-Related Side Effects and Adverse Reactions; Glucur | 2010 |
Elvitegravir: a once-daily, boosted, HIV-1 integrase inhibitor.
Topics: Adenine; Carbamates; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clinical | 2012 |
Considerations regarding antiretroviral chemoprophylaxis in MSM.
Topics: Adenine; Administration, Oral; Animals; Anti-HIV Agents; Chemoprevention; Clinical Trials as Topic; | 2012 |
Rectal microbicide development.
Topics: Adenine; Administration, Rectal; Administration, Topical; Anilides; Anti-HIV Agents; Chemoprevention | 2012 |
12 trials available for adenine and Adverse Drug Event
| Article | Year |
|---|---|
Tenofovir alafenamide plus dolutegravir as a switch strategy in HIV-infected patients: a pilot randomized controlled trial.
Topics: Adenine; Anti-HIV Agents; Drug Therapy, Combination; Drug-Related Side Effects and Adverse Reactions | 2023 |
Brief Report: Efficacy and Safety of Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide (E/C/F/TAF) in Virologically Suppressed Women.
Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cobicistat; Double- | 2018 |
Duvelisib: a new phosphoinositide-3-kinase inhibitor in chronic lymphocytic leukemia.
Topics: Adenine; Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Cl | 2019 |
Early upper digestive tract side effects of zidovudine with tenofovir plus emtricitabine in West African adults with high CD4 counts.
Topics: Adenine; Adult; Anti-HIV Agents; CD4 Lymphocyte Count; Cote d'Ivoire; Deoxycytidine; Drug Therapy, C | 2013 |
Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial.
Topics: Adenine; Adolescent; Adult; Aged; Antiviral Agents; Asian People; China; DNA, Viral; Double-Blind Me | 2015 |
Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial.
Topics: Adenine; Adolescent; Adult; Aged; Antiviral Agents; Asian People; China; DNA, Viral; Double-Blind Me | 2015 |
Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial.
Topics: Adenine; Adolescent; Adult; Aged; Antiviral Agents; Asian People; China; DNA, Viral; Double-Blind Me | 2015 |
Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial.
Topics: Adenine; Adolescent; Adult; Aged; Antiviral Agents; Asian People; China; DNA, Viral; Double-Blind Me | 2015 |
Long-term efficacy and safety of tenofovir disoproxil fumarate in HIV-1-infected adolescents failing antiretroviral therapy: the final results of study GS-US-104-0321.
Topics: Adenine; Adolescent; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Bone Density; Child; Do | 2015 |
A randomized, open-label study of the safety and efficacy of switching stavudine or zidovudine to tenofovir disoproxil fumarate in HIV-1-infected children with virologic suppression.
Topics: Adenine; Adolescent; Anti-HIV Agents; Child; Child, Preschool; Drug-Related Side Effects and Adverse | 2015 |
The CLL12 trial protocol: a placebo-controlled double-blind Phase III study of ibrutinib in the treatment of early-stage chronic lymphocytic leukemia patients with risk of early disease progression.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Disease Progression; Disease-Free Survival; Double-Blind Me | 2015 |
Effectiveness and safety of generic fixed-dose combination of tenofovir/emtricitabine/efavirenz in HIV-1-infected patients in Western India.
Topics: Adenine; Adolescent; Adult; Aged; Alkynes; Anti-HIV Agents; Benzoxazines; Cyclopropanes; Deoxycytidi | 2008 |
Simplification of antiretroviral therapy with tenofovir-emtricitabine or abacavir-Lamivudine: a randomized, 96-week trial.
Topics: Adenine; Adult; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Deoxycytidine; Dideoxynucleo | 2009 |
A randomized trial to assess anti-HIV activity in female genital tract secretions and soluble mucosal immunity following application of 1% tenofovir gel.
Topics: Adenine; Adult; Anti-HIV Agents; Biomarkers; Double-Blind Method; Drug-Related Side Effects and Adve | 2011 |
Pharmacokinetics and safety of tenofovir disoproxil fumarate on coadministration with lopinavir/ritonavir.
Topics: Adenine; Area Under Curve; Cross-Over Studies; Dose-Response Relationship, Drug; Drug Administration | 2006 |
28 other studies available for adenine and Adverse Drug Event
| Article | Year |
|---|---|
Treatment patterns, adverse events, healthcare resource use and costs among commercially insured patients with mantle cell lymphoma in the United States.
Topics: Adenine; Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; | 2019 |
Recurrent Uveitis Related to Ibrutinib for Treatment of Chronic Lymphocytic Leukemia.
Topics: Adenine; Drug-Related Side Effects and Adverse Reactions; Humans; Leukemia, Lymphocytic, Chronic, B- | 2022 |
[79-year-old man with a unilateral arm lump].
Topics: Adenine; Aged; Arm; Drug-Related Side Effects and Adverse Reactions; Humans; Lymphedema; Male; Piper | 2021 |
Toxicities and outcomes of 616 ibrutinib-treated patients in the United States: a real-world analysis.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Disease Progression; Drug-Related Side Effects and Adverse | 2018 |
Molecular Mechanisms for Species Differences in Organic Anion Transporter 1, OAT1: Implications for Renal Drug Toxicity.
Topics: Adenine; Amino Acids; Animals; Antiviral Agents; Cell Line; Cercopithecidae; Dogs; Drug-Related Side | 2018 |
Comorbidities predict inferior outcomes in chronic lymphocytic leukemia treated with ibrutinib.
Topics: Adenine; Aged; Aged, 80 and over; Comorbidity; Drug-Related Side Effects and Adverse Reactions; Elec | 2018 |
Rates of switching antiretroviral drugs in a primary care service in South Africa before and after introduction of tenofovir.
Topics: Adenine; Adult; Anti-Retroviral Agents; Antiretroviral Therapy, Highly Active; Cohort Studies; Drug | 2013 |
[Efficacy and tolerability of antiretroviral therapy containing tenofovir disoproxil fumarate-emtricitabine-efavirenz in treatment-naive patients infected with HIV-1 in Bobo Dioulasso (Burkina Faso, 2009-2011)].
Topics: Adenine; Adult; Anti-Retroviral Agents; Burkina Faso; Deoxycytidine; Drug Combinations; Drug-Related | 2013 |
Efficacy of 2years of entecavir plus adefovir therapy in patients with chronic hepatitis B who had failed on prior nucleos(t)ide analog treatment.
Topics: Adenine; Adult; Alanine Transaminase; Antiviral Agents; Cohort Studies; DNA, Viral; Drug Therapy, Co | 2014 |
Safety and efficacy of coformulated efavirenz/emtricitabine/tenofovir single-tablet regimen in treatment-naive patients infected with HIV-1.
Topics: Adenine; Adult; Alkynes; Anti-HIV Agents; Benzoxazines; CD4 Lymphocyte Count; Cyclopropanes; Deoxycy | 2015 |
Prophylactic treatment with a novel bioadhesive gel formulation containing aciclovir and tenofovir protects from HSV-2 infection.
Topics: Acrylic Resins; Acyclovir; Adenine; Animals; Anti-Infective Agents; Chlorocebus aethiops; Disease Mo | 2014 |
Bone and kidney toxicity induced by nucleotide analogues in patients affected by HBV-related chronic hepatitis: a longitudinal study.
Topics: Adenine; Adult; Aged; Antiviral Agents; Bone Diseases; Drug-Related Side Effects and Adverse Reactio | 2015 |
Commentary: The place of tenofovir disoproxil fumarate in pediatric antiretroviral therapy.
Topics: Adenine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Drug Utilization; Drug-Related Side | 2015 |
Efficacy, safety and pharmacokinetics of tenofovir disoproxil fumarate in virologic-suppressed HIV-infected children using weight-band dosing.
Topics: Adenine; Adolescent; Alkynes; Anti-HIV Agents; Benzoxazines; Bone Density; Calcium; CD4 Lymphocyte C | 2015 |
Immucillins ImmA and ImmH Are Effective and Non-toxic in the Treatment of Experimental Visceral Leishmaniasis.
Topics: Adenine; Adenosine; Animals; Antibodies, Protozoan; Antiprotozoal Agents; Blood Chemical Analysis; D | 2015 |
Editorial.
Topics: Adenine; Alanine; Anti-HIV Agents; Clinical Trials as Topic; Drug Approval; Drug-Related Side Effect | 2016 |
Long-term outcomes for patients with chronic lymphocytic leukemia who discontinue ibrutinib.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Deprescriptions; Disease Progression; Drug-Related Side Eff | 2017 |
Rosiglitazone reverses tenofovir-induced nephrotoxicity.
Topics: Adenine; Animals; Drug-Related Side Effects and Adverse Reactions; Glomerular Filtration Rate; Hypog | 2008 |
Combination of Lamivudine and adefovir therapy in HBeAg-positive chronic hepatitis B patients with poor response to adefovir monotherapy.
Topics: Adenine; Adolescent; Adult; Antiviral Agents; DNA, Viral; Drug Therapy, Combination; Drug-Related Si | 2010 |
The art of managing human immunodeficiency virus infection: a balancing act.
Topics: Adenine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Deoxycytidine; Dideoxynucleosides; | 2009 |
Second-line treatment in the Malawi antiretroviral programme: high early mortality, but good outcomes in survivors, despite extensive drug resistance at baseline.
Topics: Adenine; Adolescent; Adult; Anti-Retroviral Agents; Body Mass Index; CD4 Lymphocyte Count; Developin | 2010 |
Economic efficiency of genetic screening to inform the use of abacavir sulfate in the treatment of HIV.
Topics: Adenine; Adult; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Computer Simulation; Cost-Be | 2010 |
Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria.
Topics: Adenine; Adolescent; Adult; Alkynes; Anti-Retroviral Agents; Benzoxazines; Cohort Studies; Cycloprop | 2012 |
Long-term efficacy and safety of lamivudine, entecavir, and tenofovir for treatment of hepatitis B virus-related cirrhosis.
Topics: Adenine; Adult; Aged; Alanine Transaminase; Antiviral Agents; Blood Chemical Analysis; Drug Therapy, | 2013 |
New drugs 2002, part III.
Topics: Adenine; Anti-Bacterial Agents; Anti-HIV Agents; Anti-Infective Agents; Antihypertensive Agents; Ant | 2002 |
[Experimental studies of the preventive and curative effectiveness of adenine in hematological damage caused by acute benzol intoxication].
Topics: Adenine; Benzene; Drug-Related Side Effects and Adverse Reactions; Hematologic Diseases; Humans; Psy | 1959 |
Anti-HBV nucleotide prodrug analogs: synthesis, bioreversibility, and cytotoxicity studies.
Topics: Adenine; Animals; Antiviral Agents; Cattle; Drug-Related Side Effects and Adverse Reactions; Hepatit | 2006 |
[Hyperuricemia and gout--diagnosis].
Topics: Adenine; Adult; Diagnosis, Differential; Drug-Related Side Effects and Adverse Reactions; Female; Go | 2002 |