Matheron S, Brun-Vezinet F, Viraben R, Malkin JE, Troisvallets D, Lafeuillade A, Thiaux C, Mamet JP; International Conference on AIDS.
Int Conf AIDS. 2000 Jul 9-14; 13: abstract no. WeOrB605.
S. Matheron, Hosp.Bicat, 46,rue Henri Huchard, 75877 paris, France, Tel.: +33 1 40 257 809, Fax: +33 1 42 295 300, E-mail: ct6916@ggr.co.uk
Objective: To evaluate COM/ ABC as first line therapy in HIV-1 infected adults, in place of a PI containing triple combination. Methods: ART naive adults, with a plasma HIV-1 RNA (pVL) between 1000 and 500000 cp/ml were randomized to receive either COM (3TC150mg/ZDV300mg) bid + ABC (300mg) bid or COM bid + Viracept (NFV) (750mg) q8h for 48weeks (w). pVL (Roche Amplicor > 50 cp/ml), CD4+ cell count, clinical, biological adverse events, and adherence to regimen were assessed at baseline, w 4,8,16,24,32,40 and 48. Results: 195 subjects, median age 34 years (18-68), 131 males, 64 females, were randomised, 98 subjects to COM/ABC and 97 to COM/NFV. At baseline pVL was comparable in both groups with a median pVL of 4.2 log10 (1.7-5.4).Median CD4+cell count/mm3 was lower at baseline in COM/ABC (387 (10-1038)) than in COM/NFV (449 (29-1133)) (p > 0.004). In this intent to treat analysis, 78% and 74% of subjects had pVL> 50 cp/ml in COM/ABC and COM/NFV respectively and 83% and 80% of subjects had pVL> 400 cp/ml. % of subjects with pVL>50 cp/ml and without switch of study drug, was 67% in both groups. Median change from baseline in pVL was -2.4 log10 (-3.5; 0.5) in both group. Median CD4+ cell count increase was 90 (-168, +701) in COM/ABC and 75 (-767, +741) in COM/NFV. Number of subjects experiencing > = 1 drug related Serious Adverse Event (SAE) was similar in both groups (3 in COM/ABC, 2 in COM/NFV), excluding hypersensitivity reaction to ABC (4 cases reported). 7 subjects (4%) permanently discontinued > = 1 study drug as a result of an SAE. Conclusion: The triple nucleoside combination Combivir/Abacavir was shown to be a potent and safe first line ART in HIV-1 infected adults with a comparable efficacy to a PI containing regimen at 24 weeks
Publication Types:
Keywords:
- Adult
- Antiretroviral Therapy, Highly Active
- CD4 Lymphocyte Count
- Clinical Protocols
- Combivir
- Dideoxynucleosides
- Drug Combinations
- Drug Therapy, Combination
- Female
- HIV Protease Inhibitors
- HIV-1
- Humans
- Lamivudine
- Male
- Nelfinavir
- Protease Inhibitors
- Zidovudine
- abacavir
- drug therapy
- therapy
Other ID:
UI: 102240295
From Meeting Abstracts