Abstract | BACKGROUND: METHODS: A randomized, open-label, parallel-group, multicenter study to compare the efficacy and safety of the FDC group to the separate entities (SE) group, in combination with tenofovir and a new protease inhibitor or nonnucleoside reverse transcription inhibitor in antiretroviral-experienced adults experiencing virologic failure (VF). Eligible subjects had viral loads >1000 copies/mL with < or =3 nucleoside reverse transcription inhibitor-associated mutations. The primary efficacy end point was time-average changed from baseline (average area under the curve minus baseline) in plasma HIV-1 RNA over 48 weeks. RESULTS: A total of 186 subjects were enrolled. The average area under the curve minus baseline was -1.65 and -1.83 log10 copies/mL in the FDC and SE groups, respectively (intention to treat; 95% confidence interval: -0.13, 0.38). Patients in the FDC (50%) and SE groups (47%) achieved viral loads <50 copies/mL based on the time to loss of virologic response algorithm. VF was low and similar in both groups (FDC, 16%; SE, 18%). Tolerability was similar between the 2 groups. CONCLUSIONS: The FDC group had noninferior efficacy over 48 weeks to the SE group in treatment-experienced subjects with VF.
|
Authors | Anthony Lamarca, Nathan Clumeck, Andreas Plettenberg, Pere Domingo, Kaisong Fu, Charles Craig, Henry Zhao, Maria Watson, David Gordon, Trevor Scott |
Journal | Journal of acquired immune deficiency syndromes (1999)
(J Acquir Immune Defic Syndr)
Vol. 41
Issue 5
Pg. 598-606
(Apr 15 2006)
ISSN: 1525-4135 [Print] United States |
PMID | 16652033
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Anti-HIV Agents
- Dideoxynucleosides
- Lamivudine
- abacavir
|
Topics |
- Adult
- Aged
- Anti-HIV Agents
(administration & dosage, therapeutic use)
- Dideoxynucleosides
(administration & dosage, therapeutic use)
- Drug Administration Schedule
- Drug Therapy, Combination
- Female
- HIV Infections
(drug therapy)
- HIV-1
- Humans
- Lamivudine
(administration & dosage, therapeutic use)
- Male
- Middle Aged
- Safety
|