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Efficacy and safety of ritonavir-boosted dual protease inhibitor therapy in antiretroviral-naive HIV-1-infected patients: the 2IP ANRS 127 study.
- Source :
-
The Journal of antimicrobial chemotherapy [J Antimicrob Chemother] 2009 Jul; Vol. 64 (1), pp. 118-25. Date of Electronic Publication: 2009 May 06. - Publication Year :
- 2009
-
Abstract
- Objectives: We evaluate the efficacy and tolerability of ritonavir-boosted dual protease inhibitor as a nucleoside reverse transcriptase inhibitor-sparing regimen in a prospective open-label randomized pilot trial in antiretroviral-naive patients.<br />Methods: Thirty patients received fosamprenavir/atazanavir/ritonavir (Group 1) and 31 patients received saquinavir/atazanavir/ritonavir (Group 2). The primary endpoint for efficacy was the rate of early virological success, defined as plasma viral load <50 copies/mL at week 16. The study is registered with ClinicalTrials.gov (NCT00122603).<br />Results: At baseline, median (range) viral load was 4.8 log(10) copies/mL (4.0-5.7) and the median CD4 cell count was 271/mm(3) (197-740). Viral load was <50 copies/mL in 12/30 patients [40%, 95% confidence interval (CI) 23%-58%] and 13/31 patients (42%, 95% CI 25%-59%) at week 16 in Groups 1 and 2, respectively. Patients with failing regimens (viral load >or=400 copies/mL at week 16 or >or=50 copies/mL at week 24) were switched to a standard antiretroviral regimen. At week 48, by an intention-to-treat analysis, 23/30 patients (77%) and 26/31 patients (84%) had plasma HIV-1 RNA <50 copies/mL in Groups 1 and 2, respectively. Four patients discontinued treatment for adverse events, all before week 4. No major changes in the protease gene were detected at treatment failure relative to baseline. Baseline viral load <50 000 copies/mL was the only predictor of virological success at week 16.<br />Conclusions: Ritonavir-boosted dual protease inhibitor regimens targeting only one step of viral replication were insufficient to rapidly suppress plasma HIV RNA to <50 copies/mL in antiretroviral-naive patients with high viral load at baseline.
- Subjects :
- Adult
Anti-HIV Agents adverse effects
Anti-HIV Agents therapeutic use
Antiretroviral Therapy, Highly Active adverse effects
Asparagine adverse effects
Asparagine analogs & derivatives
Asparagine therapeutic use
Atazanavir Sulfate
CD4 Lymphocyte Count
Carbamates adverse effects
Carbamates therapeutic use
Female
Furans
Humans
Male
Middle Aged
Oligopeptides adverse effects
Oligopeptides therapeutic use
Organophosphates adverse effects
Organophosphates therapeutic use
Pyridines adverse effects
Pyridines therapeutic use
Quinolines adverse effects
Quinolines therapeutic use
RNA, Viral blood
Sulfonamides adverse effects
Sulfonamides therapeutic use
Treatment Outcome
Viral Load
Antiretroviral Therapy, Highly Active methods
HIV Infections drug therapy
HIV Protease Inhibitors adverse effects
HIV Protease Inhibitors therapeutic use
HIV-1 drug effects
Ritonavir adverse effects
Ritonavir therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1460-2091
- Volume :
- 64
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- The Journal of antimicrobial chemotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 19420019
- Full Text :
- https://doi.org/10.1093/jac/dkp146