alanine has been researched along with Weight Gain in 40 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.
Weight Gain: Increase in BODY WEIGHT over existing weight.
| Excerpt | Relevance | Reference |
|---|---|---|
| " This review aims to summarise the recent evidence investigating the associations between the use of integrase inhibitors and tenofovir alafenamide (TAF) with weight gain and the mechanisms by which this may occur." | 9.12 | Impact of Integrase inhibitors and tenofovir alafenamide on weight gain in people with HIV. ( Lake, JE; Trevillyan, J, 2021) |
| "We aimed to determine the reversibility of at least 7% weight gain within 12 months following tenofovir alafenamide (TAF) and/or integrase strand transfer inhibitor (INSTI) discontinuation in people with HIV (PWH) from the Dutch ATHENA cohort." | 8.31 | No evidence of rapid reversibility of tenofovir alafenamide and/or integrase strand transfer inhibitor-associated weight gain. ( Boyd, A; Reiss, P; Van der Valk, M; Verburgh, ML; Wit, FWNM, 2023) |
| "As cardiovascular diseases represent the main cause of non-AIDS related death in people living with HIV (PLWH) with undetectable viral load, we evaluated lipid profile, weight gain and calculated cardiovascular risk change after switching from tenofovir disoproxil fumarate (TDF)-based regimens to tenofovir alafenamide (TAF)-based regimens." | 8.02 | Impact of switch from tenofovir disoproxil fumarate-based regimens to tenofovir alafenamide-based regimens on lipid profile, weight gain and cardiovascular risk score in people living with HIV. ( Darcis, G; Fombellida, K; Frippiat, F; Lecomte, M; Léonard, P; Maes, N; Meuris, C; Moutschen, M; Paquot, N; Plum, PE; Sauvage, AS; Uurlings, F; Vaira, D, 2021) |
| "To investigate whether the switch from tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) to tenofovir alafenamide (TAF)/FTC/RPV is associated with weight gain in people living with HIV (PLWHIV)." | 7.96 | The switch from tenofovir disoproxil fumarate to tenofovir alafenamide determines weight gain in patients on rilpivirine-based regimen. ( Berruti, M; Briano, F; Di Biagio, A; Taramasso, L, 2020) |
| "Olanzapine-induced weight gain is associated with atherosclerosis, hypertension, dyslipidemia, and diabetes." | 7.83 | Attenuated Weight Gain with the Novel Analog of Olanzapine Linked to Sarcosinyl Moiety (PGW5) Compared to Olanzapine. ( Gil-Ad, I; Globus, R; Shbiro, L; Taler, M; Vered, I; Weizman, A; Weller, A, 2016) |
| "Olanzapine is a second-generation antipsychotic that may cause weight gain and metabolic syndrome in some cases." | 7.75 | The association of olanzapine-induced weight gain with peroxisome proliferator-activated receptor-gamma2 Pro12Ala polymorphism in patients with schizophrenia. ( Akin, F; Aydin, N; Barlas, O; Erdal, M; Herken, H; Karadag, F; Sengul, C, 2009) |
| "Studies from different countries around the world have shown that integrase inhibitor (INSTI)-based regimens as well as tenofovir alafenamide (TAF) are associated with weight gain, with women and people of black race at especially high risk." | 5.22 | Metabolic Consequences of Antiretroviral Therapy. ( Diggins, CE; Lo, J; Russo, SC, 2022) |
| "Recent evidence continues to contribute to the evidence for weight gain associated with INSTIs, especially when used with newer nucleoside reverse transcriptase inhibitor, tenofovir alafenamide (TAF)." | 5.12 | Risks of metabolic syndrome and diabetes with integrase inhibitor-based therapy. ( Hill, A; Shah, S, 2021) |
| " This review aims to summarise the recent evidence investigating the associations between the use of integrase inhibitors and tenofovir alafenamide (TAF) with weight gain and the mechanisms by which this may occur." | 5.12 | Impact of Integrase inhibitors and tenofovir alafenamide on weight gain in people with HIV. ( Lake, JE; Trevillyan, J, 2021) |
| "We aimed to determine the reversibility of at least 7% weight gain within 12 months following tenofovir alafenamide (TAF) and/or integrase strand transfer inhibitor (INSTI) discontinuation in people with HIV (PWH) from the Dutch ATHENA cohort." | 4.31 | No evidence of rapid reversibility of tenofovir alafenamide and/or integrase strand transfer inhibitor-associated weight gain. ( Boyd, A; Reiss, P; Van der Valk, M; Verburgh, ML; Wit, FWNM, 2023) |
| "As cardiovascular diseases represent the main cause of non-AIDS related death in people living with HIV (PLWH) with undetectable viral load, we evaluated lipid profile, weight gain and calculated cardiovascular risk change after switching from tenofovir disoproxil fumarate (TDF)-based regimens to tenofovir alafenamide (TAF)-based regimens." | 4.02 | Impact of switch from tenofovir disoproxil fumarate-based regimens to tenofovir alafenamide-based regimens on lipid profile, weight gain and cardiovascular risk score in people living with HIV. ( Darcis, G; Fombellida, K; Frippiat, F; Lecomte, M; Léonard, P; Maes, N; Meuris, C; Moutschen, M; Paquot, N; Plum, PE; Sauvage, AS; Uurlings, F; Vaira, D, 2021) |
| " However, emerging data from clinical trials has identified excessive weight gain possibly due to INSTI alone or with tenofovir alafenamide as a new and possible long-term complication of combination antiretroviral therapy (cART)." | 4.02 | Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide discontinuation and return to normal weight. ( DeMarais, P; Max, B, 2021) |
| "Although weight gain has been reported with the use of integrase strand transfer inhibitors (InSTI), concurrent use of tenofovir alafenamide (TAF) has been implicated in recent studies." | 4.02 | Weight gain before and after switch from TDF to TAF in a U.S. cohort study. ( Beyer, AP; Brunet, L; Fusco, GP; Fusco, JS; Hsu, RK; Mallon, PW; Mounzer, KC; Prajapati, G; Wohlfeiler, MB, 2021) |
| "To investigate whether the switch from tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) to tenofovir alafenamide (TAF)/FTC/RPV is associated with weight gain in people living with HIV (PLWHIV)." | 3.96 | The switch from tenofovir disoproxil fumarate to tenofovir alafenamide determines weight gain in patients on rilpivirine-based regimen. ( Berruti, M; Briano, F; Di Biagio, A; Taramasso, L, 2020) |
| "Olanzapine-induced weight gain is associated with atherosclerosis, hypertension, dyslipidemia, and diabetes." | 3.83 | Attenuated Weight Gain with the Novel Analog of Olanzapine Linked to Sarcosinyl Moiety (PGW5) Compared to Olanzapine. ( Gil-Ad, I; Globus, R; Shbiro, L; Taler, M; Vered, I; Weizman, A; Weller, A, 2016) |
| "Olanzapine is a second-generation antipsychotic that may cause weight gain and metabolic syndrome in some cases." | 3.75 | The association of olanzapine-induced weight gain with peroxisome proliferator-activated receptor-gamma2 Pro12Ala polymorphism in patients with schizophrenia. ( Akin, F; Aydin, N; Barlas, O; Erdal, M; Herken, H; Karadag, F; Sengul, C, 2009) |
| "Vitamin B6 deficiency was induced in mice by maintenance for 4 weeks on a vitamin B6-free diet." | 1.28 | Tryptophan metabolism in vitamin B6-deficient mice. ( Bender, DA; Danielian, PS; Njagi, EN, 1990) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 7 (17.50) | 18.2507 |
| 2000's | 6 (15.00) | 29.6817 |
| 2010's | 7 (17.50) | 24.3611 |
| 2020's | 20 (50.00) | 2.80 |
| Authors | Studies |
|---|---|
| Plum, PE | 1 |
| Maes, N | 1 |
| Sauvage, AS | 1 |
| Frippiat, F | 1 |
| Meuris, C | 1 |
| Uurlings, F | 1 |
| Lecomte, M | 1 |
| Léonard, P | 1 |
| Paquot, N | 1 |
| Fombellida, K | 1 |
| Vaira, D | 1 |
| Moutschen, M | 1 |
| Darcis, G | 1 |
| Calza, L | 1 |
| Borderi, M | 1 |
| Colangeli, V | 1 |
| Miani, T | 1 |
| Nuti, B | 1 |
| Bon, I | 1 |
| Lazzarotto, T | 1 |
| Viale, P | 1 |
| Diggins, CE | 1 |
| Russo, SC | 1 |
| Lo, J | 1 |
| Schafer, JJ | 1 |
| Zimmerman, M | 1 |
| Walshe, C | 1 |
| Cerankowski, J | 1 |
| Shimada, A | 1 |
| Keith, SW | 1 |
| Kauppinen, KJ | 1 |
| Aho, I | 1 |
| Sutinen, J | 1 |
| Verburgh, ML | 1 |
| Wit, FWNM | 1 |
| Boyd, A | 1 |
| Reiss, P | 1 |
| Van der Valk, M | 1 |
| Kuo, PH | 1 |
| Sun, HY | 1 |
| Chuang, YC | 1 |
| Wu, PY | 1 |
| Liu, WC | 1 |
| Hung, CC | 1 |
| Taramasso, L | 1 |
| Berruti, M | 1 |
| Briano, F | 1 |
| Di Biagio, A | 1 |
| Ruderman, SA | 1 |
| Crane, HM | 1 |
| Nance, RM | 1 |
| Whitney, BM | 1 |
| Harding, BN | 1 |
| Mayer, KH | 1 |
| Moore, RD | 1 |
| Eron, JJ | 1 |
| Geng, E | 1 |
| Mathews, WC | 1 |
| Rodriguez, B | 1 |
| Willig, AL | 1 |
| Burkholder, GA | 1 |
| Lindström, S | 1 |
| Wood, BR | 1 |
| Collier, AC | 1 |
| Vannappagari, V | 1 |
| Henegar, C | 1 |
| Van Wyk, J | 2 |
| Curtis, L | 1 |
| Saag, MS | 1 |
| Kitahata, MM | 1 |
| Delaney, JAC | 1 |
| Max, B | 1 |
| DeMarais, P | 1 |
| Shah, S | 1 |
| Hill, A | 1 |
| Bae, EJ | 1 |
| Choi, WG | 1 |
| Pagire, HS | 1 |
| Pagire, SH | 1 |
| Parameswaran, S | 1 |
| Choi, JH | 1 |
| Yoon, J | 1 |
| Choi, WI | 1 |
| Lee, JH | 1 |
| Song, JS | 1 |
| Bae, MA | 1 |
| Kim, M | 1 |
| Jeon, JH | 1 |
| Lee, IK | 1 |
| Kim, H | 1 |
| Ahn, JH | 1 |
| Ait-Khaled, M | 1 |
| Santos, J | 1 |
| Scholten, S | 1 |
| Wohlfeiler, M | 1 |
| Ajana, F | 1 |
| Jones, B | 1 |
| Nascimento, MC | 1 |
| Tenorio, AR | 1 |
| Smith, DE | 1 |
| Wright, J | 1 |
| Wynne, B | 1 |
| Surial, B | 1 |
| Mugglin, C | 1 |
| Calmy, A | 1 |
| Cavassini, M | 1 |
| Günthard, HF | 1 |
| Stöckle, M | 1 |
| Bernasconi, E | 1 |
| Schmid, P | 1 |
| Tarr, PE | 1 |
| Furrer, H | 1 |
| Ledergerber, B | 1 |
| Wandeler, G | 1 |
| Rauch, A | 1 |
| Lake, JE | 1 |
| Trevillyan, J | 1 |
| Mallon, PW | 1 |
| Brunet, L | 1 |
| Hsu, RK | 1 |
| Fusco, JS | 1 |
| Mounzer, KC | 1 |
| Prajapati, G | 1 |
| Beyer, AP | 1 |
| Wohlfeiler, MB | 1 |
| Fusco, GP | 1 |
| Yeoh, DK | 1 |
| Campbell, AJ | 1 |
| Bowen, AC | 1 |
| Sjaarda, A | 1 |
| Bernstein, A | 1 |
| Sparks, A | 1 |
| Saber, S | 1 |
| Siegel, M | 1 |
| Darnell, J | 1 |
| Jain, S | 1 |
| Sun, X | 1 |
| Qin, H | 1 |
| Reynolds, T | 1 |
| Karris, MY | 1 |
| Hill, LA | 1 |
| Chai, J | 1 |
| Diao, Q | 1 |
| Zhao, J | 1 |
| Wang, H | 1 |
| Deng, K | 1 |
| Qi, M | 1 |
| Nie, M | 1 |
| Zhang, N | 1 |
| Gomez, M | 1 |
| Seybold, U | 1 |
| Roider, J | 1 |
| Härter, G | 1 |
| Bogner, JR | 1 |
| Sun, Y | 1 |
| Wu, Z | 1 |
| Li, W | 1 |
| Zhang, C | 1 |
| Sun, K | 1 |
| Ji, Y | 1 |
| Wang, B | 1 |
| Jiao, N | 1 |
| He, B | 1 |
| Wang, W | 1 |
| Dai, Z | 1 |
| Wu, G | 2 |
| Taler, M | 1 |
| Vered, I | 1 |
| Globus, R | 1 |
| Shbiro, L | 1 |
| Weizman, A | 1 |
| Weller, A | 1 |
| Gil-Ad, I | 1 |
| Getty, CM | 1 |
| Almeida, FN | 1 |
| Baratta, AA | 1 |
| Dilger, RN | 1 |
| Zhang, B | 1 |
| Lin, M | 1 |
| Yu, C | 1 |
| Li, J | 1 |
| Zhang, L | 1 |
| Zhou, P | 1 |
| Yang, W | 1 |
| Gao, F | 1 |
| Zhou, G | 1 |
| Nall, JL | 1 |
| Kim, KH | 1 |
| Choi, CW | 1 |
| Smith, SB | 1 |
| Herken, H | 1 |
| Erdal, M | 1 |
| Aydin, N | 1 |
| Sengul, C | 1 |
| Karadag, F | 1 |
| Barlas, O | 1 |
| Akin, F | 1 |
| de Kort, SW | 1 |
| Hokken-Koelega, AC | 1 |
| Vaccaro, O | 1 |
| Lapice, E | 1 |
| Monticelli, A | 1 |
| Giacchetti, M | 1 |
| Castaldo, I | 1 |
| Galasso, R | 1 |
| Pinelli, M | 1 |
| Donnarumma, G | 1 |
| Rivellese, AA | 1 |
| Cocozza, S | 1 |
| Riccardi, G | 1 |
| Caparroz-Assef, SM | 1 |
| Bersani-Amado, CA | 1 |
| Kelmer-Bracht, AM | 1 |
| Bracht, A | 1 |
| Ishii-Iwamoto, EL | 1 |
| Tanaka, H | 1 |
| Nakajima, J | 1 |
| Mori, M | 1 |
| Ogura, M | 1 |
| Kraus, A | 1 |
| Roth, HP | 1 |
| Kirchgessner, M | 1 |
| Podolin, DA | 1 |
| Wei, Y | 1 |
| Pagliassotti, MJ | 1 |
| Lindi, V | 1 |
| Sivenius, K | 1 |
| Niskanen, L | 1 |
| Laakso, M | 1 |
| Uusitupa, MI | 1 |
| Stumvoll, M | 1 |
| Häring, H | 1 |
| Horigome, T | 1 |
| Cho, YS | 1 |
| Morand, C | 1 |
| Rémésy, C | 1 |
| Levrat, MA | 1 |
| Demigné, C | 1 |
| Bender, DA | 1 |
| Njagi, EN | 1 |
| Danielian, PS | 1 |
| Furuse, M | 1 |
| Yang, SI | 1 |
| Shirai, K | 1 |
| Okumura, J | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Lamivudine in HIV-1 Infected Adults Who Are Virologically Suppressed[NCT03446573] | Phase 3 | 743 participants (Actual) | Interventional | 2018-01-18 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented. (NCT03446573)
Timeframe: Up to Week 48
| Intervention | Participants (Count of Participants) |
|---|---|
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. (NCT03446573)
Timeframe: Up to Week 144
| Intervention | Participants (Count of Participants) |
|---|---|
| DTG+3TC FDC (Early Switch) | 23 |
| TAF-based Regimen (Early Switch) | 7 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented. (NCT03446573)
Timeframe: Up to Week 48
| Intervention | Participants (Count of Participants) |
|---|---|
| DTG+3TC FDC (Early Switch) | 13 |
| TAF Based Regimen (Early Switch) | 2 |
Percentage of participants with plasma HIV-1 RNA <50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Percentage values are rounded off. (NCT03446573)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| DTG+3TC FDC (Early Switch) | 95 |
| TAF Based Regimen (Early Switch) | 96 |
Percentage of participants with plasma HIV-1 RNA <50 c/mL (virologic success) was evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG +3TC once daily compared to continuation of TBR over 48 weeks. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. (NCT03446573)
Timeframe: Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| DTG+3TC FDC (Early Switch) | 93.2 |
| TAF Based Regimen (Early Switch) | 93.0 |
Percentage of participants with plasma HIV-1 RNA >=50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. (NCT03446573)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| DTG+3TC FDC (Early Switch) | 0.3 |
| TAF Based Regimen (Early Switch) | 0.8 |
Percentage of participants with virologic failure (plasma HIV-1 RNA >=50 c/mL) was evaluated using FDA snapshot algorithm at Week 48. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. Intent-to-treat exposed (ITT-E) Population comprises of all randomized participants who received at least one dose of study treatment either DTG + 3TC or TBR. Participants were assessed according to the treatment to which the participant was randomized. Any participant receiving a treatment randomization number was considered to be randomized. (NCT03446573)
Timeframe: Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| DTG+3TC FDC (Early Switch) | 0.3 |
| TAF Based Regimen (Early Switch) | 0.5 |
"Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value was latest pre-dose assessment (Day 1) with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, BMI (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Nanomoles per liter (Mean) | |
|---|---|---|
| Week 24, n=351, 355 | Week 48, n=344, 343 | |
| DTG+3TC FDC (Early Switch) | 0.0 | -5.8 |
| TAF Based Regimen (Early Switch) | 2.1 | -3.5 |
"Serum samples were collected for the analysis of 25-hydroxyvitamin D. Baseline value was the value from latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum 25-hydroxyvitamin D in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Nanomoles per liter (Number) |
|---|---|
| Week 24, n=1 | |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 2 |
"Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Nanomoles per liter (Mean) | |
|---|---|---|
| Week 96, n=315, 291 | Week 144, n=315, 303 | |
| DTG+3TC FDC (Early Switch) | -11.5 | -7.5 |
| TAF Based Regimen (Early Switch) | -2.2 | -1.9 |
"Serum samples were collected for analysis of bone biomarkers. Baseline is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Micrograms per liter (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Bone-ALP, Week 96, n=316, 289 | Bone-ALP, Week 144, n=314, 301 | Osteocalcin, Week 96, n=315 , 288 | Osteocalcin, Week 144, n=315, 301 | P1NP, Week 96, n=316 ,290 | P1NP, Week 144, n=315, 302 | CTX-1, Week 96 ,n=315, 289 | CTX-1, Week 48, n=315, 300 | |
| DTG+3TC FDC (Early Switch) | -0.62 | -0.27 | -1.97 | -0.74 | 6.7 | 3.9 | 0.0201 | 0.0022 |
| TAF Based Regimen (Early Switch) | -0.79 | -0.40 | -0.10 | 1.21 | 4.7 | 3.5 | 0.0050 | -0.0104 |
"Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1) . Change from Baseline is post-dose visit value minus Baseline value. Change from Baseline in bone biomarkers-serum bone-specific ALP (Bone-ALP), osteocalcin, serum P1NP and serum CTX-1 in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Micrograms per liter (Number) | |||
|---|---|---|---|---|
| Bone-ALP, Week 24, n=1 | Osteocalcin, Week 24, n=1 | P1NP, Week24, n=1 | CTX-1, Week 24,n=1 | |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 0.3 | 13.4 | 11 | 0.045 |
"Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, body mass index (BMI) (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Micrograms per liter (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Bone-ALP, Week 24, n=350, 354 | Bone-ALP, Week 48, n=343, 342 | Osteocalcin, Week 24, n=350 ,353 | Osteocalcin, Week 48, n=343, 342 | P1NP, Week24, n=349 ,356 | P1NP, Week48, n=342, 343 | CTX-1, Week 24,n=350,356 | CTX-1, Week 48, n=343, 343 | |
| DTG+3TC FDC (Early Switch) | -0.77 | -0.03 | -1.08 | -1.15 | 7.0 | 9.3 | 0.0350 | 0.0602 |
| TAF-based Regimen (Early Switch) | -1.05 | -0.34 | 0.26 | 0.69 | 5.0 | 6.4 | -0.0031 | 0.0310 |
"CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Cells per cubic millimeter (Median) | |
|---|---|---|
| Week 24, n=351, 359 | Week 48, n=344, 345 | |
| DTG+3TC FDC (Early Switch) | 21.0 | 22.5 |
| TAF Based Regimen (Early Switch) | 6.0 | 11.0 |
"CD4+ cells are a type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+and evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Cells per cubic millimeter (Median) | |
|---|---|---|
| Week 96, n=315, 295 | Week 144, n=309, 301 | |
| DTG+3TC FDC (Early Switch) | 61.0 | 36.0 |
| TAF-based Regimen (Early Switch) | 45.0 | 35.0 |
"Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over 48 Weeks. Baseline (Day 1) values were the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable ." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Ratio (Median) | |
|---|---|---|
| Week 24, n=346, 358 | Week 48, n=342, 343 | |
| DTG+3TC FDC (Early Switch) | 0.010 | 0.030 |
| TAF Based Regimen (Early Switch) | 0.040 | 0.050 |
"Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio and were evaluated by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over Weeks 96 and 144. Baseline (Day 1) values are the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the TBR (TAF-based regimen) arm as efficacy of TAF and TDF are comparable" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Ratio (Median) | |
|---|---|---|
| Week 96, n=312, 292 | Week 144, n=307, 300 | |
| DTG+3TC FDC (Early Switch) | 0.035 | 0.060 |
| TAF-based Regimen (Early Switch) | 0.080 | 0.100 |
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset. Baseline was the latest pre-dose assessment value with a non-missing value (Day 1) and change from Baseline is defined as post-dose value minus Baseline value. (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Scores on a scale (Mean) | |
|---|---|---|
| Week 24 | Week 48 | |
| DTG+3TC FDC (Early Switch) | 1.2 | 1.1 |
| TAF Based Regimen (Early Switch) | 1.3 | 1.7 |
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Scores on a scale (Mean) | |
|---|---|---|
| Week 96, n=364, 369 | Week 144, n=364, 368 | |
| DTG+3TC FDC (Early Switch) | 0.7 | 0.2 |
| TAF Based Regimen (Early Switch) | 1.9 | 1.4 |
EQ-5D-5L questionnaire provides profile of participant function and global health state rating. Five-item measure has 1question assessing each of 5dimensions:mobility,self-care,usual activities,pain/discomfort,anxiety/depression and 5 levels for each dimension including 1=no problems,2=slight problems,3=moderate problems,4=severe problems,5=extreme problems. Health state is defined by combining levels of answers from each of 5 questions. Each health state is referred to in terms of a 5 digit code.Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state.EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.Baseline is latest pre-dose assessment value with a non-missing value (Day 1).Change from Baseline is post-dose visit value minus Baseline value. (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Scores on a scale (Mean) | |
|---|---|---|
| Week 96, n=364, 370 | Week 144, n=364, 369 | |
| DTG+3TC FDC (Early Switch) | -0.0036 | -0.0151 |
| TAF Based Regimen (Early Switch) | -0.0038 | -0.0042 |
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Scores on a scale (Mean) | |
|---|---|---|
| Week 24 | Week 48 | |
| DTG+3TC FDC (Early Switch) | 0.0029 | 0.0037 |
| TAF Based Regimen (Early Switch) | 0.0046 | 0.0023 |
"Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma high density lipoprotein (HDL) cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48
| Intervention | Millimoles per liter (Median) | |||||||
|---|---|---|---|---|---|---|---|---|
| Plasma cholesterol, Week 24, n=282, 264 | Plasma cholesterol, Week 48, n=275, 263 | Plasma LDL Cholesterol, Week 24, n=282, 264 | Plasma LDL Cholesterol, Week 48, n=275, 263 | Plasma Triglycerides, Week 24, n=282, 264 | Plasma Triglycerides, Week 48, n=275, 263 | Plasma HDL Cholesterol, Week 24, n=282, 264 | Plasma HDL Cholesterol, Week 48, n=275, 263 | |
| DTG+3TC FDC (Early Switch) | -0.325 | -0.200 | -0.210 | -0.170 | -0.100 | -0.100 | -0.050 | 0.000 |
| TAF Based Regimen (Early Switch) | 0.000 | 0.100 | -0.060 | 0.070 | 0.060 | 0.100 | 0.050 | 0.050 |
"Blood samples were collected at Baseline (Day 1), weeks 24 and 48 visit (participant withdrew from the study at Week 36) to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for fasting lipids in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48
| Intervention | Millimoles per liter (Number) | |||
|---|---|---|---|---|
| Plasma cholesterol, Week 24, n=1 | Plasma LDL Cholesterol, Week 24, n=1 | Plasma Triglycerides, Week 24, n=1 | Plasma HDL Cholesterol, Week 24, n=1 | |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 0 | -0.67 | 1.36 | 0.05 |
"Blood samples were collected at Baseline (Day 1), Weeks 96 and 144 to assess fasting lipids which includes plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value is the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Millimoles per liter (Median) | |||||||
|---|---|---|---|---|---|---|---|---|
| Plasma cholesterol, Week 96, n=238, 213 | Plasma cholesterol, Week 144, n=243, 230 | Plasma LDL Cholesterol, Week 96, n=238, 213 | Plasma LDL Cholesterol, Week 144, n=243, 230 | Plasma Triglycerides, Week 96, n=238, 213 | Plasma Triglycerides, Week 144, n=243, 230 | Plasma HDL Cholesterol, Week 96, n=238, 213 | Plasma HDL Cholesterol, Week 144, n=243, 230 | |
| DTG+3TC FDC (Early Switch) | -3.7 | -4.0 | -5.6 | -5.0 | -2.1 | -9.4 | -3.8 | -3.8 |
| TAF Based Regimen (Early Switch) | 1.2 | 3.8 | 1.7 | 4.2 | 4.9 | 2.2 | 0.0 | 3.8 |
"Serum samples assessed: renal inflammation biomarker serum creatinine.Baseline(Day 1)was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Micromoles per liter (Mean) | |
|---|---|---|
| Week 24, n=351, 359 | Week 48, n=344, 345 | |
| DTG+3TC FDC (Early Switch) | 7.47 | 6.67 |
| TAF Based Regimen (Early Switch) | 3.11 | 2.18 |
"Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - serum creatinine. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum creatinine in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Micromoles per liter (Number) |
|---|---|
| Week 24, n=1 | |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | -8 |
"Serum samples were collected to assess renal inflammation biomarker - serum creatinine. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Micromoles per liter (Mean) | |
|---|---|---|
| Week 96, n=316, 294 | Week 144, n=311, 302 | |
| DTG+3TC FDC (Early Switch) | 5.53 | 9.25 |
| TAF-based Regimen (Early Switch) | 0.58 | 5.17 |
"Serum samples were collected to assess renal biomarker. Baseline was latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for following:treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Milligrams per liter (Mean) | |
|---|---|---|
| Week 24, n=351, 357 | Week 48, n=344, 343 | |
| DTG+3TC FDC (Early Switch) | -0.03 | 0.00 |
| TAF Based Regimen (Early Switch) | -0.02 | 0.01 |
"Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - cystatin C. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum cystatin -C biomarker in TDF based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Milligrams per liter (Number) |
|---|---|
| Week 24, n=1 | |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 0 |
"Serum samples were collected to assess renal biomarker. Baseline is latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Milligrams per liter (Mean) | |
|---|---|---|
| Week 96, n=316, 290 | Week 144, n=315, 302 | |
| DTG+3TC FDC (Early Switch) | 0.07 | 0.13 |
| TAF-based Regimen (Early Switch) | 0.10 | 0.14 |
"Serum samples assessed:serum GFR from cystatin C and from creatinine adjusted using CKD-EPI Baseline(Day 1) was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value.Adjusted mean and standard error is presented.Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class,CD4+ cell count(continuous),age(continuous), sex, race, BMI(continuous),presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Milliliters/minute/1.73*meter square (Mean) | |||
|---|---|---|---|---|
| GFR from cystatin C CKD-EPI, Week 24, n=351, 357 | GFR from cystatin C CKD-EPI, Week 48, n=344, 343 | GFR from creatinine CKD-EPI, Week 24, n=351, 359 | GFR from creatinine CKD-EPI, Week 48, n=344, 345 | |
| DTG+3TC FDC (Early Switch) | 3.2 | 0.1 | -8.8 | -7.7 |
| TAF Based Regimen (Early Switch) | 1.5 | -1.6 | -3.8 | -2.9 |
"Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarkers - serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48
| Intervention | Milliliters/minute/1.73*meter square (Number) | |
|---|---|---|
| GFR from cystatin C CKD-EPI, Week 24, n=1 | GFR from creatinine CKD-EPI, Week 24, n=1 | |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 0 | 4 |
"Serum samples were collected to assess serum GFR from cystatin C and from creatinine adjusted for BSA. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Milliliters/minute/1.73*meter square (Mean) | |||
|---|---|---|---|---|
| GFR from cystatin C CKD-EPI, Week 96, n=316, 290 | GFR from cystatin C CKD-EPI, Week 144, n=315, 302 | GFR from creatinine adjusted for BSA, Week 96, n=315, 294 | GFR from creatinine adjusted for BSA, Week 144, n=311, 300 | |
| DTG+3TC FDC (Early Switch) | -7.6 | -13.9 | -7.2 | -11.5 |
| TAF Based Regimen (Early Switch) | -11.7 | -15.8 | -1.9 | -7.0 |
"Urine samples were collected at Baseline, Week 24 and Week 48 to assess renal biomarkers - urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline was defined as the latest pre-dose assessment value with a non-missing value. (Day 1). Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Change from Baseline in UP/C was calculated as UP/C ratio at post-Baseline visit minus UP/C ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48
| Intervention | Ratio (Number) | |
|---|---|---|
| UA/C, Week 24, n=1 | UP/C, Week 24, n=1 | |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 0 | 0.3 |
"Urine samples were collected at Baseline, Weeks 96 and 144. Baseline is defined as Day 1. Change from Baseline in UA/C is defined as UA/C ratio at post-Baseline visit minus UA/C ratio at Baseline. Change from Baseline in UP/C and UA/C is defined as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio at Baseline, respectively. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Ratio (Geometric Mean) | |||
|---|---|---|---|---|
| UA/C, Week 96, n=208, 175 | UA/C, Week 144, n=202, 179 | UP/C, Week 96, n=245, 206 | UP/C, Week 144, n=237, 220 | |
| DTG+3TC FDC (Early Switch) | 1.058 | 1.203 | 1.048 | 1.182 |
| TAF-based Regimen (Early Switch) | 1.075 | 1.200 | 1.105 | 1.188 |
"Urine samples were collected at Baseline, Week 24 and Week 48. Baseline is defined as Day 1. Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. Change from Baseline in UP/C and UA/C was calculated as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio calculated at Baseline, respectively. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48
| Intervention | Ratio (Geometric Mean) | |||
|---|---|---|---|---|
| UA/C, Week 24, n=235, 230 | UA/C, Week 48, n=230, 224 | UP/C, Week 24, n=267, 261 | UP/C, Week 48, n=261, 257 | |
| DTG+3TC FDC (Early Switch) | 1.080 | 1.125 | 0.955 | 0.971 |
| TAF Based Regimen (Early Switch) | 1.022 | 1.059 | 0.976 | 1.016 |
"Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine beta-2 microglobulin/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48
| Intervention | Ratio (Geometric Mean) | |
|---|---|---|
| Week 24, n=136, 141 | Week 48, n=126, 141 | |
| DTG+3TC FDC (Early Switch) | 0.991 | 0.973 |
| TAF Based Regimen (Early Switch) | 1.034 | 0.922 |
"Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine is defined as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Ratio (Geometric Mean) | |
|---|---|---|
| Week 96, n=109, 107 | Week 144, n=101, 97 | |
| DTG+3TC FDC (Early Switch) | 1.080 | 0.904 |
| TAF-based Regimen (Early Switch) | 0.986 | 0.958 |
"Urine biomarker samples were collected at Baseline and at Weeks 24 and 48 to assess urine phosphate. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48
| Intervention | Ratio (Geometric Mean) | |
|---|---|---|
| Week 24, n=348, 352 | Week 48, n=342, 340 | |
| DTG+3TC FDC (Early Switch) | 0.955 | 0.969 |
| TAF Based Regimen (Early Switch) | 0.940 | 0.970 |
"Urine biomarker samples were collected to assess urine phosphate. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48
| Intervention | Ratio (Number) |
|---|---|
| Week 24, n=1 | |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 2.9 |
"Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine phosphate. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate is defined as urine phosphate at post-Baseline visit minus urine phosphate at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Ratio (Geometric Mean) | |
|---|---|---|
| Week 96, n=312, 286 | Week 144, n=313, 298 | |
| DTG+3TC FDC (Early Switch) | 0.960 | 0.890 |
| TAF Based Regimen (Early Switch) | 0.978 | 0.912 |
"Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine retinol binding protein 4/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio was calculated as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48
| Intervention | Ratio (Geometric Mean) | |
|---|---|---|
| Week 24, n=344, 343 | Week 48, n=340, 335 | |
| DTG+3TC FDC (Early Switch) | 0.860 | 1.063 |
| TAF Based Regimen (Early Switch) | 0.920 | 1.068 |
"Urine biomarker samples were collected to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine retinol binding protein 4/urine creatinine was calculated as urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen." (NCT03446573)
Timeframe: Baseline (Day 1) and at weeks 24 and 48
| Intervention | Ratio (Number) |
|---|---|
| Week 24, n=1 | |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 1.04 |
"Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio is defined as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm Randomized to TBR but received TDF-based regimen" (NCT03446573)
Timeframe: Baseline (Day 1) and at Weeks 96 and 144
| Intervention | Ratio (Geometric Mean) | |
|---|---|---|
| Week 96, n=310, 282 | Week 144, n=304, 288 | |
| DTG+3TC FDC (Early Switch) | 0.926 | 1.188 |
| TAF Based Regimen (Early Switch) | 0.851 | 1.227 |
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of TDF-based regimen participants with adverse events by maximum grade have been presented. (NCT03446573)
Timeframe: Up to Week 48
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 0 | 1 | 0 | 0 | 0 |
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Number of TDF-based regimen participants with any SAE and common (>=2%) non-SAEs are presented. (NCT03446573)
Timeframe: Up to Week 48
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Any non-SAE (>=2%) | Any SAE | |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 1 | 0 |
samples were collected up to the Week 36 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. (NCT03446573)
Timeframe: Up to Week 36
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALT, Grade 1 | ALT, Grade 2 | ALT, Grade 3 | ALT, Grade 4 | Albumin, Grade 1 | Albumin, Grade 2 | Albumin, Grade 3 | Albumin, Grade 4 | ALP, Grade 1 | ALP, Grade 2 | ALP, Grade 3 | ALP, Grade 4 | AST, Grade 1 | AST, Grade 2 | AST, Grade 3 | AST, Grade 4 | Bilirubin, Grade 1 | Bilirubin, Grade 2 | Bilirubin, Grade 3 | Bilirubin, Grade 4 | CO2, Grade 1 | CO2, Grade 2 | CO2, Grade 3 | CO2, Grade 4 | Cholesterol, Grade 1 | Cholesterol, Grade 2 | Cholesterol, Grade 3 | Cholesterol, Grade 4 | CK, Grade 1 | CK, Grade 2 | CK, Grade 3 | CK, Grade 4 | Creatinine, Grade 1 | Creatinine, Grade 2 | Creatinine, Grade 3 | Creatinine, Grade 4 | Direct bilirubin, Grade 1 | Direct bilirubin, Grade 2 | Direct bilirubin, Grade 3 | Direct bilirubin, Grade 4 | GFR from creatinine adjusted using CKD EPI,Grade 1 | GFR from creatinine adjusted using CKD EPI,Grade 2 | GFR from creatinine adjusted using CKD EPI,Grade 3 | GFR from creatinine adjusted using CKD EPI,Grade 4 | GFR from cystatin C adjusted using CKD-EPI,Grade 1 | GFR from cystatin C adjusted using CKD-EPI,Grade 2 | GFR from cystatin C adjusted using CKD-EPI,Grade 3 | GFR from cystatin C adjusted using CKD-EPI,Grade 4 | Hypercalcemia, Grade 1 | Hypercalcemia, Grade 2 | Hypercalcemia, Grade 3 | Hypercalcemia, Grade 4 | Hyperglycemia, Grade 1 | Hyperglycemia, Grade 2 | Hyperglycemia, Grade 3 | Hyperglycemia, Grade 4 | Hyperkalemia, Grade 1 | Hyperkalemia, Grade 2 | Hyperkalemia, Grade 3 | Hyperkalemia, Grade 4 | Hypernatremia, Grade 1 | Hypernatremia, Grade 2 | Hypernatremia, Grade 3 | Hypernatremia, Grade 4 | Hypocalcemia, Grade 1 | Hypocalcemia, Grade 2 | Hypocalcemia, Grade 3 | Hypocalcemia, Grade 4 | Hypoglycemia, Grade 1 | Hypoglycemia, Grade 2 | Hypoglycemia, Grade 3 | Hypoglycemia, Grade 4 | Hypokalemia, Grade 1 | Hypokalemia, Grade 2 | Hypokalemia, Grade 3 | Hypokalemia, Grade 4 | Hyponatremia, Grade 1 | Hyponatremia, Grade 2 | Hyponatremia, Grade 3 | Hyponatremia, Grade 4 | LDL cholesterol, Grade 1 | LDL cholesterol, Grade 2 | LDL cholesterol, Grade 3 | LDL cholesterol, Grade 4 | Phosphate, Grade 1 | Phosphate, Grade 2 | Phosphate, Grade 3 | Phosphate, Grade 4 | Triglycerides, Grade 1 | Triglycerides, Grade 2 | Triglycerides, Grade 3 | Triglycerides, Grade 4 | |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Blood samples were collected up to the Week 36 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those TDF-based regimen participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented. (NCT03446573)
Timeframe: Up to Week 36
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hemoglobin, Grade 1 | Hemoglobin, Grade 2 | Hemoglobin, Grade 3 | Hemoglobin, Grade 4 | Leukocytes, Grade 1 | Leukocytes, Grade 2 | Leukocytes, Grade 3 | Leukocytes, Grade 4 | Neutrophils, Grade 1 | Neutrophils, Grade 2 | Neutrophils, Grade 3 | Neutrophils, Grade 4 | Platelets, Grade 1 | Platelets, Grade 2 | Platelets, Grade 3 | Platelets, Grade 4 | |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. (NCT03446573)
Timeframe: Up to Week 144
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
| DTG+3TC FDC (Early Switch) | 57 | 217 | 50 | 9 | 3 |
| TAF Based Regimen (Early Switch) | 65 | 208 | 54 | 8 | 0 |
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. (NCT03446573)
Timeframe: Up to Week 48
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
| DTG+3TC FDC (Early Switch) | 102 | 170 | 19 | 3 | 1 |
| TAF Based Regimen (Early Switch) | 94 | 177 | 15 | 6 | 0 |
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment (NCT03446573)
Timeframe: Up to Week 148
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Any non-SAE (>=2%) | Any SAE | |
| DTG+3TC FDC (Early Switch) | 307 | 57 |
| TAF-based Regimen (Early Switch) | 304 | 44 |
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Safety Population included all participants who received at least one dose of study treatment either DTG + 3TC or TBR. This population was based on the treatment the participant actually received. Number of participants with any SAE and common (>=2%) non-SAEs are presented. (NCT03446573)
Timeframe: Up to Week 48
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Any non-SAE (>=2%) | Any SAE | |
| DTG+3TC FDC (Early Switch) | 222 | 21 |
| TAF Based Regimen (Early Switch) | 204 | 16 |
HIV-associated conditions were recorded during the study and were assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV were: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: >=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3:Documented AIDS defining condition or CD4+ T-lymphocye count <200 cells/mcL. Disease progression summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death. (NCT03446573)
Timeframe: At Weeks 24 and 48
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| From CDC Stage 1 to CDC Stage 3 Event | From CDC Stage 2 to CDC Stage 3 Event | From CDC Stage 3 to new CDC Stage 3 Event | From CDC Stage 1, 2 or 3 to Death | No HIV-1 disease progression | |
| DTG+3TC FDC (Early Switch) | 1 | 0 | 0 | 1 | 367 |
| TAF Based Regimen (Early Switch) | 0 | 0 | 0 | 0 | 372 |
HIV-associated conditions were recorded during the study and assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV is: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: >=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3: Documented AIDS-defining condition or CD4+ T-lymphocye count <200 cells/mcL. Indicators of clinical disease progression is defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death. (NCT03446573)
Timeframe: At Weeks 96 and 144
| Intervention | Participants (Count of Participants) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 96, From CDC Stage 1 to CDC Stage 3 Event | Week 96, From CDC Stage 2 to CDC Stage 3 Event | Week 96, From CDC Stage 3 to new CDC Stage 3 Event | Week 96, From CDC Stage 1, 2 or 3 to Death | Week 96, No HIV-1 disease progression | Week 144, From CDC Stage 1 to CDC Stage 3 Event | Week 144, From CDC Stage 2 to CDC Stage 3 Event | Week 144,From CDC Stage 3 to new CDC Stage 3 Event | Week 144, From CDC Stage 1, 2 or 3 to Death | Week 144, No HIV-1 disease progression | |
| DTG+3TC FDC (Early Switch) | 2 | 0 | 0 | 2 | 365 | 2 | 0 | 0 | 3 | 364 |
| TAF-based Regimen (Early Switch) | 0 | 0 | 0 | 0 | 372 | 0 | 1 | 0 | 0 | 371 |
Plasma samples were collected for drug resistance testing. Number of participants, who meet CVW criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with genotypic resistance to INSTI, NRTI, NNRTI and PI are summarized. (NCT03446573)
Timeframe: Up to Week 144
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| INSTI | NRTI | NNRTI | PI | |
| TAF Based Regimen (Early Switch) | 0 | 0 | 0 | 0 |
Plasma samples were collected for drug resistance testing. Number of participants, who met confirmed virologic withdrawal (CVW) criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with genotypic resistance to INSTI, nucleoside reverse transcriptase inhibitor (NRTI), NNRTI and PI was summarized. (NCT03446573)
Timeframe: Up to Week 48
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| INSTI | NRTI | NNRTI | PI | |
| TAF Based Regimen (Early Switch) | 0 | 0 | 0 | 0 |
Blood samples were collected up to Week 144 for the analysis of clinical chemistry parameters: ALT, albumin, ALP, AST, bilirubin, CO2, cholesterol, CK, creatinine, direct bilirubin, GFR from creatinine adjusted for BSA, GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, LDL cholesterol, phosphate triglycerides and lactate dehydrogenase. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. (NCT03446573)
Timeframe: Up to Week 144
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALT, Grade 1 | ALT, Grade 2 | ALT, Grade 3 | ALT, Grade 4 | Albumin, Grade 1 | Albumin, Grade 2 | Albumin, Grade 3 | Albumin, Grade 4 | ALP, Grade 1 | ALP, Grade 2 | ALP, Grade 3 | ALP, Grade 4 | AST, Grade 1 | AST, Grade 2 | AST, Grade 3 | AST, Grade 4 | Bilirubin, Grade 1 | Bilirubin, Grade 2 | Bilirubin, Grade 3 | Bilirubin, Grade 4 | CO2, Grade 1 | CO2, Grade 2 | CO2, Grade 3 | CO2, Grade 4 | Cholesterol, Grade 1 | Cholesterol, Grade 2 | Cholesterol, Grade 3 | Cholesterol, Grade 4 | CK, Grade 1 | CK, Grade 2 | CK, Grade 3 | CK, Grade 4 | Creatinine, Grade 1 | Creatinine, Grade 2 | Creatinine, Grade 3 | Creatinine, Grade 4 | Direct bilirubin, Grade 1 | Direct bilirubin, Grade 2 | Direct bilirubin, Grade 3 | Direct bilirubin, Grade 4 | GFR from creatinine adjusted using CKD EPI,Grade 1 | GFR from creatinine adjusted using CKD EPI,Grade 2 | GFR from creatinine adjusted using CKD EPI,Grade 3 | GFR from creatinine adjusted using CKD EPI,Grade 4 | GFR from cystatin C adjusted using CKD-EPI,Grade 1 | GFR from cystatin C adjusted using CKD-EPI,Grade 2 | GFR from cystatin C adjusted using CKD-EPI,Grade 3 | GFR from cystatin C adjusted using CKD-EPI,Grade 4 | Hypercalcemia, Grade 1 | Hypercalcemia, Grade 2 | Hypercalcemia, Grade 3 | Hypercalcemia, Grade 4 | Hyperglycemia, Grade 1 | Hyperglycemia, Grade 2 | Hyperglycemia, Grade 3 | Hyperglycemia, Grade 4 | Hyperkalemia, Grade 1 | Hyperkalemia, Grade 2 | Hyperkalemia, Grade 3 | Hyperkalemia, Grade 4 | Hypernatremia, Grade 1 | Hypernatremia, Grade 2 | Hypernatremia, Grade 3 | Hypernatremia, Grade 4 | Hypocalcemia, Grade 1 | Hypocalcemia, Grade 2 | Hypocalcemia, Grade 3 | Hypocalcemia, Grade 4 | Hypoglycemia, Grade 1 | Hypoglycemia, Grade 2 | Hypoglycemia, Grade 3 | Hypoglycemia, Grade 4 | Hypokalemia, Grade 1 | Hypokalemia, Grade 2 | Hypokalemia, Grade 3 | Hypokalemia, Grade 4 | Hyponatremia, Grade 1 | Hyponatremia, Grade 2 | Hyponatremia, Grade 3 | Hyponatremia, Grade 4 | LDL cholesterol, Grade 1 | LDL cholesterol, Grade 2 | LDL cholesterol, Grade 3 | LDL cholesterol, Grade 4 | Phosphate, Grade 1 | Phosphate, Grade 2 | Phosphate, Grade 3 | Phosphate, Grade 4 | Triglycerides, Grade 1 | Triglycerides, Grade 2 | Triglycerides, Grade 3 | Triglycerides, Grade 4 | Lactate Dehydrogenase Grade 1 | Lactate Dehydrogenase Grade 2 | Lactate Dehydrogenase Grade 3 | Lactate Dehydrogenase Grade 4 | |
| DTG+3TC FDC (Early Switch) | 55 | 11 | 5 | 0 | 1 | 2 | 0 | 0 | 6 | 0 | 0 | 0 | 34 | 13 | 3 | 3 | 24 | 9 | 3 | 0 | 110 | 2 | 1 | 0 | 42 | 26 | 1 | 0 | 41 | 12 | 12 | 10 | 21 | 5 | 1 | 0 | 0 | 0 | 13 | 0 | 0 | 165 | 38 | 0 | 0 | 169 | 46 | 1 | 8 | 0 | 0 | 0 | 73 | 40 | 4 | 0 | 3 | 2 | 0 | 0 | 4 | 1 | 0 | 0 | 14 | 1 | 0 | 0 | 9 | 4 | 0 | 0 | 10 | 3 | 1 | 0 | 21 | 0 | 0 | 0 | 41 | 19 | 8 | 0 | 61 | 3 | 0 | 0 | 60 | 6 | 6 | 4 | 0 | 0 | 0 | 0 |
| TAF Based Regimen (Early Switch) | 49 | 9 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 45 | 9 | 0 | 3 | 12 | 4 | 1 | 0 | 97 | 4 | 0 | 0 | 70 | 34 | 2 | 0 | 30 | 13 | 12 | 10 | 12 | 2 | 1 | 0 | 0 | 0 | 3 | 0 | 0 | 101 | 24 | 1 | 0 | 183 | 58 | 1 | 9 | 0 | 0 | 0 | 77 | 31 | 4 | 0 | 2 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 5 | 2 | 0 | 0 | 10 | 3 | 0 | 0 | 7 | 0 | 0 | 0 | 26 | 2 | 0 | 0 | 56 | 24 | 9 | 0 | 71 | 9 | 0 | 0 | 77 | 15 | 5 | 2 | 1 | 0 | 0 | 0 |
Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), GFR from cystatin C adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. (NCT03446573)
Timeframe: Up to Week 48
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALT, Grade 1 | ALT, Grade 2 | ALT, Grade 3 | ALT, Grade 4 | Albumin, Grade 1 | Albumin, Grade 2 | Albumin, Grade 3 | Albumin, Grade 4 | ALP, Grade 1 | ALP, Grade 2 | ALP, Grade 3 | ALP, Grade 4 | AST, Grade 1 | AST, Grade 2 | AST, Grade 3 | AST, Grade 4 | Bilirubin, Grade 1 | Bilirubin, Grade 2 | Bilirubin, Grade 3 | Bilirubin, Grade 4 | CO2, Grade 1 | CO2, Grade 2 | CO2, Grade 3 | CO2, Grade 4 | Cholesterol, Grade 1 | Cholesterol, Grade 2 | Cholesterol, Grade 3 | Cholesterol, Grade 4 | CK, Grade 1 | CK, Grade 2 | CK, Grade 3 | CK, Grade 4 | Creatinine, Grade 1 | Creatinine, Grade 2 | Creatinine, Grade 3 | Creatinine, Grade 4 | Direct bilirubin, Grade 1 | Direct bilirubin, Grade 2 | Direct bilirubin, Grade 3 | Direct bilirubin, Grade 4 | GFR from creatinine adjusted using CKD EPI,Grade 1 | GFR from creatinine adjusted using CKD EPI,Grade 2 | GFR from creatinine adjusted using CKD EPI,Grade 3 | GFR from creatinine adjusted using CKD EPI,Grade 4 | GFR from cystatin C adjusted using CKD-EPI,Grade 1 | GFR from cystatin C adjusted using CKD-EPI,Grade 2 | GFR from cystatin C adjusted using CKD-EPI,Grade 3 | GFR from cystatin C adjusted using CKD-EPI,Grade 4 | Hypercalcemia, Grade 1 | Hypercalcemia, Grade 2 | Hypercalcemia, Grade 3 | Hypercalcemia, Grade 4 | Hyperglycemia, Grade 1 | Hyperglycemia, Grade 2 | Hyperglycemia, Grade 3 | Hyperglycemia, Grade 4 | Hyperkalemia, Grade 1 | Hyperkalemia, Grade 2 | Hyperkalemia, Grade 3 | Hyperkalemia, Grade 4 | Hypernatremia, Grade 1 | Hypernatremia, Grade 2 | Hypernatremia, Grade 3 | Hypernatremia, Grade 4 | Hypocalcemia, Grade 1 | Hypocalcemia, Grade 2 | Hypocalcemia, Grade 3 | Hypocalcemia, Grade 4 | Hypoglycemia, Grade 1 | Hypoglycemia, Grade 2 | Hypoglycemia, Grade 3 | Hypoglycemia, Grade 4 | Hypokalemia, Grade 1 | Hypokalemia, Grade 2 | Hypokalemia, Grade 3 | Hypokalemia, Grade 4 | Hyponatremia, Grade 1 | Hyponatremia, Grade 2 | Hyponatremia, Grade 3 | Hyponatremia, Grade 4 | LDL cholesterol, Grade 1 | LDL cholesterol, Grade 2 | LDL cholesterol, Grade 3 | LDL cholesterol, Grade 4 | Phosphate, Grade 1 | Phosphate, Grade 2 | Phosphate, Grade 3 | Phosphate, Grade 4 | Triglycerides, Grade 1 | Triglycerides, Grade 2 | Triglycerides, Grade 3 | Triglycerides, Grade 4 | |
| DTG+3TC FDC (Early Switch) | 24 | 6 | 1 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 21 | 7 | 1 | 1 | 17 | 5 | 1 | 0 | 73 | 1 | 0 | 0 | 27 | 12 | 1 | 0 | 28 | 4 | 9 | 6 | 16 | 3 | 0 | 0 | 0 | 0 | 8 | 0 | 0 | 135 | 26 | 0 | 0 | 52 | 5 | 1 | 7 | 0 | 0 | 0 | 56 | 21 | 2 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 8 | 0 | 0 | 0 | 5 | 3 | 0 | 0 | 7 | 1 | 0 | 0 | 8 | 0 | 0 | 0 | 28 | 13 | 6 | 0 | 38 | 2 | 0 | 0 | 34 | 4 | 4 | 4 |
| TAF Based Regimen (Early Switch) | 18 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 29 | 4 | 0 | 0 | 7 | 2 | 1 | 0 | 70 | 1 | 0 | 0 | 52 | 19 | 0 | 0 | 19 | 9 | 8 | 5 | 7 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 83 | 13 | 0 | 0 | 66 | 4 | 0 | 3 | 0 | 0 | 0 | 64 | 19 | 2 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 6 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 13 | 2 | 0 | 0 | 35 | 15 | 3 | 0 | 47 | 7 | 0 | 0 | 48 | 11 | 4 | 0 |
Blood samples were collected up to Week 144 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters are were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. (NCT03446573)
Timeframe: Up to Week 144
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hemoglobin, Grade 1 | Hemoglobin, Grade 2 | Hemoglobin, Grade 3 | Hemoglobin, Grade 4 | Leukocytes, Grade 1 | Leukocytes, Grade 2 | Leukocytes, Grade 3 | Leukocytes, Grade 4 | Neutrophils, Grade 1 | Neutrophils, Grade 2 | Neutrophils, Grade 3 | Neutrophils, Grade 4 | Platelets, Grade 1 | Platelets, Grade 2 | Platelets, Grade 3 | Platelets, Grade 4 | |
| DTG+3TC FDC (Early Switch) | 7 | 1 | 0 | 0 | 2 | 1 | 1 | 0 | 5 | 3 | 0 | 2 | 8 | 2 | 0 | 0 |
| TAF Based Regimen (Early Switch) | 2 | 2 | 0 | 0 | 4 | 0 | 0 | 0 | 5 | 8 | 0 | 2 | 7 | 1 | 0 | 0 |
Blood samples were collected up to Week 48 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented. (NCT03446573)
Timeframe: Up to Week 48
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hemoglobin, Grade 1 | Hemoglobin, Grade 2 | Hemoglobin, Grade 3 | Hemoglobin, Grade 4 | Leukocytes, Grade 1 | Leukocytes, Grade 2 | Leukocytes, Grade 3 | Leukocytes, Grade 4 | Neutrophils, Grade 1 | Neutrophils, Grade 2 | Neutrophils, Grade 3 | Neutrophils, Grade 4 | Platelets, Grade 1 | Platelets, Grade 2 | Platelets, Grade 3 | Platelets, Grade 4 | |
| DTG+3TC FDC (Early Switch) | 3 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 3 | 2 | 0 | 1 | 6 | 1 | 0 | 0 |
| TAF Based Regimen (Early Switch) | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 4 | 4 | 0 | 0 | 5 | 1 | 0 | 0 |
Number of participants, who meet CVW criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with phenotypic resistance to INSTI,NNRT,NRTI and PI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented. (NCT03446573)
Timeframe: Up to Week 144
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| INSTI, DTG, Sensitive | INSTI, DTG, Resistant | INSTI, Bictegravir (BIC), Sensitive | INSTI, BIC, Resistant | INSTI, Elvitegravir (EVG), Sensitive | INSTI, EVG, Resistant | INSTI, Raltegravir (RAL), Sensitive | INSTI, RAL, Resistant | NNRTI, Delavirdine (DLV), Sensitive | NNRTI, DLV, Resistant | NNRTI, Efavirenz (EFV), Sensitive | NNRTI, EFV, Resistant | NNRTI, Etravirine (ETR), Sensitive | NNRTI, ETR, Resistant | NNRTI, Nevirapine (NVP), Sensitive | NNRTI, NVP, Resistant | NNRTI, Rilpivirine (RPV), Sensitive | NNRTI, RPV, Resistant | NRTI, 3TC, Sensitive | NRTI, 3TC, Resistant | NRTI, Abacavir (ABC), Sensitive | NRTI, ABC, Resistant | NRTI, Zidovudine (AZT), Sensitive | NRTI, AZT, Resistant | NRTI, Stavudine (D4T), Sensitive | NRTI, D4T, Resistant | NRTI, Didanosine (DDI), Sensitive | NRTI, DDI, Resistant | NRTI, Emtricitabine (FTC), Sensitive | NRTI, FTC, Resistant | NRTI, Tenofovir (TDF), Sensitive | NRTI, TDF, Resistant | PI, Atazanavir (ATV), Sensitive | PI, ATV, Resistant | PI, Darunavir (DRV), Sensitive | PI, DRV, Resistant | PI, Fosamprenavir (FPV), Sensitive | PI, FPV, Resistant | PI, Indinavir (IDV), Sensitive | PI, IDV, Resistant | PI, Lopinavir (LPV), Sensitive | PI, LPV, Resistant | PI, Nelfinavir (NFV), Sensitive | PI, NFV, Resistant | PI, Ritonavir (RTV), Sensitive | PI, RTV, Resistant | PI, Saquinavir (SQV), Sensitive | PI, SQV, Resistant | PI, Tipranavir (TPV), Sensitive | PI, TPV, Resistant | |
| TAF Based Regimen (Early Switch) | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 |
Number of participants, who meet CVW criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with phenotypic resistance to INSTI, NNRTI,NRTI and PI were summarized. Assessment of antiviral activity of ART using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented. (NCT03446573)
Timeframe: Up to Week 48
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| INSTI, DTG, Sensitive | INSTI, DTG, Resistant | INSTI, Bictegravir (BIC), Sensitive | INSTI, BIC, Resistant | INSTI, Elvitegravir (EVG), Sensitive | INSTI, EVG, Resistant | INSTI, Raltegravir (RAL), Sensitive | INSTI, RAL, Resistant | NNRTI, Delavirdine (DLV), Sensitive | NNRTI, DLV, Resistant | NNRTI, Efavirenz (EFV), Sensitive | NNRTI, EFV, Resistant | NNRTI, Etravirine (ETR), Sensitive | NNRTI, ETR, Resistant | NNRTI, Nevirapine (NVP), Sensitive | NNRTI, NVP, Resistant | NNRTI, Rilpivirine (RPV), Sensitive | NNRTI, RPV, Resistant | NRTI, 3TC, Sensitive | NRTI, 3TC, Resistant | NRTI, Abacavir (ABC), Sensitive | NRTI, ABC, Resistant | NRTI, Zidovudine (AZT), Sensitive | NRTI, AZT, Resistant | NRTI, Stavudine (D4T), Sensitive | NRTI, D4T, Resistant | NRTI, Didanosine (DDI), Sensitive | NRTI, DDI, Resistant | NRTI, Emtricitabine (FTC), Sensitive | NRTI, FTC, Resistant | NRTI, Tenofovir (TDF), Sensitive | NRTI, TDF, Resistant | PI, Atazanavir (ATV), Sensitive | PI, ATV, Resistant | PI, Darunavir (DRV), Sensitive | PI, DRV, Resistant | PI, Fosamprenavir (FPV), Sensitive | PI, FPV, Resistant | PI, Indinavir (IDV), Sensitive | PI, IDV, Resistant | PI, Lopinavir (LPV), Sensitive | PI, LPV, Resistant | PI, Nelfinavir (NFV), Sensitive | PI, NFV, Resistant | PI, Ritonavir (RTV), Sensitive | PI, RTV, Resistant | PI, Saquinavir (SQV), Sensitive | PI, SQV, Resistant | PI, Tipranavir (TPV), Sensitive | PI, TPV, Resistant | |
| TAF Based Regimen (Early Switch) | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 |
Percentage of participants with plasma HIV-1 RNA <50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144. (NCT03446573)
Timeframe: Weeks 96 and 144
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| Week 96 | Week 144 | |
| DTG+3TC FDC (Early Switch) | 85.9 | 85.9 |
| TAF-based Regimen (Early Switch) | 79.0 | 81.7 |
Percentage of participants with plasma HIV-1 RNA >=50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144. (NCT03446573)
Timeframe: Weeks 96 and 144
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| Week 96 | Week 144 | |
| DTG+3TC FDC (Early Switch) | 0.3 | 0.3 |
| TAF-based Regimen (Early Switch) | 1.1 | 1.3 |
3 reviews available for alanine and Weight Gain
| Article | Year |
|---|---|
Metabolic Consequences of Antiretroviral Therapy.
Topics: Alanine; Anti-HIV Agents; Female; Glucose; HIV Infections; HIV Integrase Inhibitors; Humans; Tenofov | 2022 |
Risks of metabolic syndrome and diabetes with integrase inhibitor-based therapy.
Topics: Alanine; Anti-HIV Agents; Diabetes Mellitus; HIV Infections; HIV Integrase Inhibitors; Humans; Metab | 2021 |
Impact of Integrase inhibitors and tenofovir alafenamide on weight gain in people with HIV.
Topics: Alanine; Anti-HIV Agents; HIV Infections; HIV Integrase Inhibitors; Humans; Tenofovir; Weight Gain | 2021 |
1 trial available for alanine and Weight Gain
| Article | Year |
|---|---|
Brief Report: Improvement in Metabolic Health Parameters at Week 48 After Switching From a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen to the 2-Drug Regimen of Dolutegravir/Lamivudine: The TANGO Study.
Topics: Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Blood Glucose; Drug Therapy, | 2021 |
36 other studies available for alanine and Weight Gain
| Article | Year |
|---|---|
Impact of switch from tenofovir disoproxil fumarate-based regimens to tenofovir alafenamide-based regimens on lipid profile, weight gain and cardiovascular risk score in people living with HIV.
Topics: Alanine; Anti-HIV Agents; Cardiovascular Diseases; Heart Disease Risk Factors; HIV Infections; Human | 2021 |
Weight gain in treatment-naive HIV-1 infected patients starting abacavir/lamivudine/dolutegravir or tenofovir alafenamide/emtricitabine/bictegravir.
Topics: Alanine; Amides; Anti-HIV Agents; Dideoxynucleosides; Emtricitabine; Heterocyclic Compounds, 3-Ring; | 2022 |
Weight changes in patients with sustained viral suppression switching tenofovir disoproxil fumarate to tenofovir alafenamide.
Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cardiovascular Diseases; Cholesterol; Drug Substitution; F | 2022 |
Switching from tenofovir alafenamide to tenofovir disoproxil fumarate improves lipid profile and protects from weight gain.
Topics: Alanine; Anti-HIV Agents; Cholesterol, LDL; Drug Substitution; HIV Infections; Humans; Retrospective | 2022 |
No evidence of rapid reversibility of tenofovir alafenamide and/or integrase strand transfer inhibitor-associated weight gain.
Topics: Adult; Alanine; Anti-Retroviral Agents; Drug Therapy, Combination; Female; HIV Infections; Humans; M | 2023 |
Weight gain and dyslipidemia among virally suppressed HIV-positive patients switching to co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide.
Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cobicistat; Dyslipi | 2020 |
The switch from tenofovir disoproxil fumarate to tenofovir alafenamide determines weight gain in patients on rilpivirine-based regimen.
Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Emtricitabine; Female; Fumarates; HIV Infections; HIV-1; H | 2020 |
Brief Report: Weight Gain Following ART Initiation in ART-Naïve People Living With HIV in the Current Treatment Era.
Topics: Adult; Alanine; Alkynes; Anti-HIV Agents; Anti-Retroviral Agents; Benzoxazines; Cyclopropanes; Dideo | 2021 |
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide discontinuation and return to normal weight.
Topics: Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cobicistat; Drug Combination | 2021 |
Peripheral Selective Oxadiazolylphenyl Alanine Derivatives as Tryptophan Hydroxylase 1 Inhibitors for Obesity and Fatty Liver Disease.
Topics: Adiposity; Alanine; Animals; Anti-Obesity Agents; Diet, High-Fat; Energy Metabolism; Enzyme Inhibito | 2021 |
Summary for Patients: Weight and Metabolic Changes After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in People Living With HIV.
Topics: Adult; Alanine; Anti-HIV Agents; HIV Infections; Humans; Lipids; Obesity; Tenofovir; Weight Gain | 2021 |
Weight and Metabolic Changes After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in People Living With HIV : A Cohort Study.
Topics: Adult; Alanine; Anti-HIV Agents; Blood Glucose; Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Fem | 2021 |
Weight gain before and after switch from TDF to TAF in a U.S. cohort study.
Topics: Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cohort Studies; Diabetes Mel | 2021 |
Increase in Body Mass Index in Children With HIV, Switched to Tenofovir Alafenamide Fumarate or Dolutegravir Containing Antiretroviral Regimens.
Topics: Adolescent; Alanine; Anti-Retroviral Agents; Body Mass Index; Child; Cohort Studies; Female; Heteroc | 2021 |
Comparison of weight gain after antiretroviral switch to integrase strand transfer inhibitor or tenofovir alafenamide-based therapy.
Topics: Alanine; Anti-HIV Agents; Drug Substitution; HIV Infections; Humans; Integrase Inhibitors; Retrospec | 2022 |
Impact of switching to tenofovir alafenamide on weight gain as compared to maintaining a non-tenofovir alafenamide containing regimen.
Topics: Alanine; Anti-HIV Agents; Body Mass Index; Case-Control Studies; Comorbidity; Female; HIV Infections | 2021 |
Effects of rearing system on meat quality, fatty acid and amino acid profiles of Hu lambs.
Topics: Alanine; Amino Acids; Animal Feed; Animal Husbandry; Animal Nutritional Physiological Phenomena; Ani | 2018 |
A retrospective analysis of weight changes in HIV-positive patients switching from a tenofovir disoproxil fumarate (TDF)- to a tenofovir alafenamide fumarate (TAF)-containing treatment regimen in one German university hospital in 2015-2017.
Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cohort Studies; Female; Fumarates; Germany; HIV Seropositi | 2019 |
Dietary L-leucine supplementation enhances intestinal development in suckling piglets.
Topics: Alanine; Amino Acid Transport Systems; Amino Acids; Animal Feed; Animals; Animals, Suckling; Dietary | 2015 |
Attenuated Weight Gain with the Novel Analog of Olanzapine Linked to Sarcosinyl Moiety (PGW5) Compared to Olanzapine.
Topics: Alanine; Animals; Antipsychotic Agents; Benzodiazepines; Female; Hypothalamus; Olanzapine; Rats; Rat | 2016 |
Plasma metabolomics indicates metabolic perturbations in low birth weight piglets supplemented with arginine.
Topics: Alanine; Amino Acids; Analysis of Variance; Animals; Animals, Suckling; Arginine; Birth Weight; Bloo | 2015 |
Alanyl-glutamine supplementation regulates mTOR and ubiquitin proteasome proteolysis signaling pathways in piglets.
Topics: Alanine; Alanine Transaminase; Animals; Aspartate Aminotransferases; Dietary Supplements; Dipeptides | 2016 |
Dietary supplementation of L-arginine and conjugated linoleic acid reduces retroperitoneal fat mass and increases lean body mass in rats.
Topics: Adipose Tissue; Alanine; Animals; Arginine; Body Weight; Carbon Dioxide; Dietary Supplements; Epidid | 2009 |
The association of olanzapine-induced weight gain with peroxisome proliferator-activated receptor-gamma2 Pro12Ala polymorphism in patients with schizophrenia.
Topics: Adult; Alanine; Antipsychotic Agents; Base Sequence; Benzodiazepines; DNA Primers; Humans; Middle Ag | 2009 |
The PPAR-gamma Pro12Ala polymorphism associates with weight gain during GH-treatment in short children born small for gestational age.
Topics: Alanine; Body Height; Child; Child, Preschool; Female; Growth Disorders; Growth Hormone; Human Growt | 2010 |
Pro12Ala polymorphism of the PPARgamma2 locus modulates the relationship between energy intake and body weight in type 2 diabetic patients.
Topics: Adult; Aged; Alanine; Amino Acid Substitution; Body Mass Index; Creatinine; Diabetes Mellitus, Type | 2007 |
The metabolic changes caused by dexamethasone in the adjuvant-induced arthritic rat.
Topics: Alanine; Ammonia; Animals; Arthritis, Experimental; Blood Glucose; Body Weight; Dexamethasone; Fasti | 2007 |
Metabolic fates of carbon skeletons of methionine, serine, and alanine in growing rats fed soybean protein diets.
Topics: Alanine; Amino Acids; Animals; Carbon; Carbon Radioisotopes; Dietary Proteins; Lipid Metabolism; Liv | 1994 |
Supplementation with vitamin C, vitamin E or beta-carotene influences osmotic fragility and oxidative damage of erythrocytes of zinc-deficient rats.
Topics: Alanine; Alkaline Phosphatase; Amino Acids; Animals; Ascorbic Acid; beta Carotene; Erythrocytes; Foo | 1997 |
Effects of a high-fat diet and voluntary wheel running on gluconeogenesis and lipolysis in rats.
Topics: Adipose Tissue; Alanine; Animals; Blood Glucose; Citrate (si)-Synthase; Deuterium; Dietary Fats; Ene | 1999 |
Effect of the Pro12Ala polymorphism of the PPAR-gamma2 gene on long-term weight change in Finnish non-diabetic subjects.
Topics: Alanine; Alternative Splicing; Amino Acid Substitution; Codon; DNA-Binding Proteins; Female; Finland | 2001 |
Reduced lipolysis as possible cause for greater weight gain in subjects with the Pro12Ala polymorphism in PPARgamma2?
Topics: Adult; Alanine; Amino Acid Substitution; Blood Glucose; Body Mass Index; Fatty Acids, Nonesterified; | 2002 |
Dietary casein and soybean protein affect the concentrations of serum cholesterol, triglyceride and free amino acids in rats.
Topics: Alanine; Amino Acids; Animals; Caseins; Cholesterol; Dietary Proteins; Digestion; Eating; Glycine; G | 1992 |
Replacement of digestible wheat starch by resistant cornstarch alters splanchnic metabolism in rats.
Topics: Alanine; Animals; Cecum; Digestive System; Eating; Fatty Acids, Volatile; Glucose; Insulin; Intestin | 1992 |
Tryptophan metabolism in vitamin B6-deficient mice.
Topics: Alanine; Animals; Cells, Cultured; Formates; Liver; Male; Mice; Mice, Inbred Strains; Tryptophan; Vi | 1990 |
Effect of alanine-producing bacteria on the growth of chicks.
Topics: Alanine; Ammonia; Animal Feed; Animals; Bacteria; Chickens; Diet; Digestive System; Eating; Male; We | 1990 |