Pollard R, Peterson D, Hardy D, Pedneault L, McLaren C, Skovronski J, Connaughton E, Grosso R, Reynolds L, Rutkiewicz V, Cross A, Dunkle L, Smaldone L; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 3rd Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 3rd 1996 Wash D C. 1996 Jan 28-Feb 1; 3rd: 89.
University of Texas Medical Branch Galveston, TX.
Subjects with previously untreated HIV infection and CD4 cell counts of 200-500/mm3 (n=89) were randomized to one of the following d4T + ddI combinations: 40 mg +200 mg, 20 mg + 200 mg, 40 mg + 100 mg, 20 mg + 100 mg, 10 mg + 100 mg (each dose was administered BID; doses were adjusted for weight less than 60 kg). Subjects who started therapy (n=67) had a median age of 31 and a median CD4 cell count of 325 at baseline. Median duration of therapy was 29 weeks; greater than or equal to 52 weeks from 16 subjects. Forty-eight subjects were evaluable for virologic response (i.e. greater than or equal to 1000 HIV RNA copies/ml at baseline, as measured by RT-PCR). Preliminary data from blinded treatment groups show a sustained median 1.4 log (10) decrease in HIV RNA and a median increase of 90 CD4 cells/mm3 at week 8. Changes in HIV RNA observed in individual subjects ranged from 0.29 log (10) increase to 2.9 log (10) decrease at week 8. Follow-up at 52 weeks is available for greater than or equal to 25% evaluable subjects; a median 2.2 log (10) decrease in HIV RNA and a median 28 CD4 cells/mm3 above baseline were observed. Of all subjects (n=67) started on therapy, one individual has experienced peripheral neuropathy which resolved, and has remained on therapy at reduced dose The following adverse events led to discontinuation in 6 subjects: grade 2-4 lipase elevation (n=3), abdominal pain (n=2), grade 4 liver transaminase elevation (n=1), grade 3 neutropenia (n=1), and grade 3 depression (n=l). These preliminary findings suggest that d4T + ddI combination therapy has potent antiviral effect and can be safely administered at several dose combinations.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- Antiviral Agents
- CD4 Lymphocyte Count
- Clinical Trials as Topic
- Didanosine
- Double-Blind Method
- HIV
- HIV Infections
- HIV Seropositivity
- Reverse Transcriptase Inhibitors
- Safety
- Stavudine
Other ID:
UI: 102216248
From Meeting Abstracts