Clumeck N, Vandenbrusene M, Delescluse J, Soele F, Farber M, Stoffels P; International Conference on AIDS.
Int Conf AIDS. 1993 Jun 6-11; 9: 468 (abstract no. PO-B26-1999).
St. Pierre Hospital, Brussels, Belgium.
INTRODUCTION: R 18893 is a molecule of a new series of NNRT-inhibitors, the alpha-APA. A phase 1 trial in 7 asymptomatic HIV-1 infected individuals showed an increase of % CD4, which remained elevated in 4 of the 6 subjects who continued to take R 18893 for 12 months. The drug was well tolerated. OBJECTIVES: To assess the effect of R 18893 on surrogate markers, on plasma and cellular viraemia and to assess the tolerance of R 18893. METHODS: Between September 1991 and September 1992, 59 HIV-1 positive, asymptomatic volunteers(CD4 > 400) were included in a randomized, double-blind placebo controlled trial. Trial subjects received orally 400 mg R 18893 t.i.d. or placebo during 3 months. Subjects were stratified for sex, age and baseline CD4 count. Immunology was performed independently in two different laboratories. Plasma and lymphocyte HIV cultures were performed by cocultivation. RESULTS: On month 2 and 3 the difference in change versus baseline between the active group and the placebo group was respectively 6% (p = 0.193) and 12% (p = 0.003) for the %CD4 and 21% (p = 0.025) and 12% (p = 0.142) for absolute CD4 count. Plasma levels were in the range of the IC 50. There was a significant reduction in time to positive virus culture in the placebo group compared with the active group (MPPW, p = 0.04) (Makush and Parks). No resistance to R 18893 was found in a selection of patients. R18893 was well tolerated. There was no significant difference in the number of adverse experiences between the two groups. CONCLUSION: In asymptomatic HIV carriers with CD4 count of > 400 cells/mm3, treatment with R 18893 showed a positive effect on surrogate markers during a 3 month treatment period. No resistance to R 18893 was observed. R 18893 needs further evaluation to determine it's long term benefit as monotherapy in asymptomatic HIV carriers.
Publication Types:
Keywords:
- Antigens, CD4
- CD4 Lymphocyte Count
- Double-Blind Method
- HIV Seropositivity
- HIV-1
- Humans
- Immune Tolerance
- Reverse Transcriptase Inhibitors
- immunology
Other ID:
UI: 102204978
From Meeting Abstracts