Table 1.
Definition of First-line Virologic Failure, Protocol-Suggested Postvirologic Failure Management, and Available Antiretroviral Therapy and Major Resistance Mutation by ACTG Study
| Definition | A5142 | A5202 | A5208 |
|---|---|---|---|
| Definition of first-line virologic failure | HIV-1 RNA <1 log10 copies/mL below baseline at/after 8 wk of ART or ≥200 copies/mL at/after 32 wk confirmation of VF was required in a subsequent plasma sample |
HIV-1 RNA ≥1000 copies/mL at/after 16 wk or ≥200 copies/mL at/after 24 wk; confirmation of VF was required in a subsequent plasma sample | HIV-1 RNA <1 log10 copies/mL below baseline at/after 12 wk or ≥400 copies/mL at/after 24 wk; confirmation of VF was required in a subsequent plasma sample |
| Protocol suggested management on first-line virologic failure | Suggested second-line regimen is EFV + additional agents selected by genotypic resistance result Alternatively, any regimen may be chosen based on the genotypic resistance test results | Subjects may remain on their study regimen in consultation with their primary care provider. If the CD4 count or the HIV-1 RNA returns to the baseline level, subjects will be strongly advised to change therapy according to resistance test result | Suggested second-line regimen is NVP-containing regimen, but switching to a second-line regimen is not mandatory. Participants may remain on the step 1 regimen at the discretion of the participant and site investigator |
| Study-provided ART | EFV, LPV/r, d4T, TDF | ABC/3TC, FTC/TDF, 3TC/ZDV, LPV/r, ABC, ATV, ddI, EFV, FTC, FPV, 3TC, d4T, RTV, TDF, ZDV | NVP, LPV/r, FTC, TDF, FTC/TDF, ddI, and ZDV |
| Definition of major resistance mutation | IAS-USA (2006 version) [12] | IAS-USA (2008 version) [13], as well as T69D, L74I, and G190C/E/Q/T/V for reverse transcriptase, and L24I, F53L, I54V/A/T/S, G73C/S/T/A, and N88D for protease | IAS-USA (2008 version) [13] |
Abbreviations: 3TC, lamivudine; ABC, abacavir; ACTG, AIDS Clinical Trials Group; ART, antiretroviral therapy; ATV, atazanavir; d4T, stavudine; ddI, didanosine; EFV, efavirenz; FPV, fosamprenavir; FTC, emtricitabine; HIV-1, human immunodeficiency virus type 1; IAS, International AIDS Society; LPV/r, lopinavir/ritonavir; NVP, nevirapine; RTV, ritonavir; TDF, tenofovir; ZDV, zidovudine.