There is one clinical trial.
This two part study will evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) after switching from a stable regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral agent in participants harboring the archived nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V and/or M184I in HIV-1 reverse transcriptase. In Part 1, participants will have M184V and/or M184I (mixtures are acceptable) in reverse transcriptase without any other NRTI resistance mutation. If the rate of virologic failure in Part 1 is deemed acceptable, once the internal data monitoring committee officially completes the interim review, the study will continue to Part 2. In Part 2, participants will have M184V and/or M184I (mixtures are acceptable) in reverse transcriptase with or without 1 or 2 thymidine analog-associated mutations.
- Proviral DNA test must not have additional exclusion resistance mutations against PIs, NRTIs and INSTIs - Part 1 (first 50 individuals): Historical genotype report must show M184V and/or M184I in reverse transcriptase WITHOUT any other NRTI resistance mutation (including thymidine analogue-associated mutations (TAMs) [TAMs are: M41L, D67N, K70R, L210W, T215Y/F, and K219Q/E/N/R], K65R, T69 insertion and Q151M mutation complex [A62V, V75I, F77L, F116Y, Q151M] - Part 2 (after the interim efficacy review - 50 individuals): Historical genotype report must show M184V and/or M184I in reverse transcriptase WITH or WITHOUT one or two thymidine analogue-associated mutations (TAMs) [TAMs are: M41L, D67N, K70R, L210W, T215Y/F, and K219Q/E/N/R]. --- M184V --- --- M184I --- --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215Y --- --- K219Q --- --- K65R --- --- Q151M --- --- A62V ---
Evidence of K65R, K70E, T69 insertion and/or Q151M mutation complex [A62V, V75I, F77L, F116Y, Q151M] will not be eligible - Currently receiving an antiretroviral regimen consisting of FTC/TDF or ABC/3TC in combination with one third antiretroviral agent for ≥ 6 consecutive months preceding the screening visit - Documented plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the screening visit - Plasma HIV-1 RNA levels < 50 copies/mL at screening visit - Estimated glomerular filtration rate (GFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance - A female individual is eligible to enter the study if it is confirmed that she is: - not pregnant - of non-childbearing potential - stopped menstruating for ≥ 12 months - of childbearing potential and agrees to utilize the protocol specified method of contraception or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following discontinuation of study drugs - Male individuals must agree to use the protocol specified method(s) of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from screening throughout the study period and for 30 days following the last study drug dose - Male individuals must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose Key Exclusion Criteria: - Individuals will have no evidence of previous virologic failure on a PI/r or INSTI-based regimen (with or without resistance to either class of ARV). --- K65R --- --- K70E --- --- Q151M --- --- A62V ---
Description: This outcome measure will be assessed with any post Day 1 sample with HIV-1 RNA ≥ 50 copies/mL.Measure: Proportion of participants with emergence of new mutations in HIV-1 reverse transcriptase and integrase Time: Up to 48 weeks