Raffi F, Reliquet V, Hascoet C, Arvieux C, Garre M, Besnier JM, Perre P, Rozenbaum W, Molina JM, Raguin G, Francois C, Auger S; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 6th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 6th 1999 Chic Ill. 1999 Jan 31-Feb 4; 6th: 186 (abstract no. 632).
Hospital of Nantes, Paris, France.
The VIRGO trial is an ongoing, open-label, non-comparative study evaluating the safety and efficacy of nevirapine (NVP)/d4T/qd ddI in 60 antiretroviral naive adults. The planned study duration was 52 weeks. At baseline, the mean CD4 count was 427 cells/microliter, and the mean plasma viral load (pVL) was 4.6 log10 copies/ml. At week 24, the mean pVL change was -2.55 log10 copies/ml (n=52) and the mean CD4 cell count change was +162/microliter. Sustained increases in CD4/45RA+ and CD4/45RO+ cells was observed. Cutaneous rash occurred in 14/60 (23%) patients, leading to NVP discontinuation in 4/14. Two other patients discontinued therapy due to hepatic cytolysis. (Table: see text) At week 36: 12/19 (63%) patients have a pVL < 50 copies/ml. The study was extended to 40 pts receiving bid d4T/qd ddI/qd NVP (200 mg/day days 1-14 then 400 mg qd). Initial results, at week 4, show a pVL reduction of 1.94 log10 copies/ml and CD4 count increases of 95 cells/microliter. The incidence of adverse events is similar to that in the first part of the study, 36 week data for the first 60 patients and 16 week data for the 40 patients on qd NVP will be available in January 1999. The d4T/ddI/NVP combination is a convenient 1st line anti-HIV regimen (7 pills) with rapid and potent immunological and antiviral effects.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Adult
- Antigens, CD4
- CD4 Lymphocyte Count
- Clinical Protocols
- Clinical Trials as Topic
- Didanosine
- HIV Infections
- HIV-1
- Humans
- Nevirapine
- Stavudine
- Viral Load
- immunology
Other ID:
UI: 102195397
From Meeting Abstracts