Roth N, Hales G, Law M, Smith D; Australasian Society for HIV Medicine. Conference.
Annu Conf Australas Soc HIV Med. 1999 Dec 9-11; 11: 97 (abstract no. OR103).
Prahan Market Clinic Melbourne, Victoria.
Introduction: CHRN 025 is a randomised, 52 week, multicentre, open label, phase III, investigator initiated study with treatment experienced HIV positive individuals. The study objectives were to assess virological and immunological outcomes. Safety and tolerability were additional measures of interest. Methods: Patients were randomised in equal proportions to one of three arms: SGC saquinavir (sqv) 800mgs tds + d4t 40mg bd + delavirdine (del) 400mgs tds; SGC saquinavir (sqv) 800mgs tds + d4t 40mg bd + nelfinavir (nel) 750mgs tds; SGC saquinavir (sqv) 400mgs bd + d4t 40mg bd + ritonavir (rit) 400 mgs bd. Prior use of non- nucleoside reverse transcriptase inhibitors or protease inhibitors (PI), other than hard gel formulation SQV, were exclusion criteria. Concurrent use of any other nucleoside reverse transcriptase inhibitors was permitted. In this preliminary analysis, no comparisons between treatment groups were performed. Analyses were based on the principal of intention to treat, with missing data treated as failure. Recruitment was closed in October 1998. Results: 75 patients were randomised into the study, of whom 73 started study medication. 96% were male with a mean age of 41 years. Mean baseline CD4+ cell count was 402 cells/mm3 and mean HIV plasma viral load was 3.71 log copies/ml. 21% of patients had a HIV plasma viral load <400 copies/ml. CD4+ cell counts increased significantly from baseline to week 24 (mean = 46 cells/ml, p<0.009), and HIV viral load decreased (mean change in log HIV viral load = 0.54, p<0.001). The percentage of people with undetectable viral load had increased to 67% at week 24. 73% of patients remained on their randomised therapy at week 24. Serious adverse events which were considered by the investigators to be probably related to study medications were two reactivations of hepatitis B, one hypersensitivity reaction to delavirdine and one death following intravenous amphetamine. The most common adverse events reported were diarrhoea, nausea, circumoral paraesthesia and rash. Conclusion: In this preliminary analysis, significant changes in CD4+ cell count or plasma HIV viral load were observed. The proportion of patients with plasma HIV viral load <400 copies/ml also increased. Final study data will be presented.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- Antiretroviral Therapy, Highly Active
- CD4 Lymphocyte Count
- Delavirdine
- Drug Therapy, Combination
- HIV
- HIV Infections
- HIV Protease Inhibitors
- HIV Seropositivity
- Humans
- Male
- Nelfinavir
- Reverse Transcriptase Inhibitors
- Ritonavir
- Saquinavir
- Stavudine
- Viral Load
- drug therapy
- organization & administration
- therapy
Other ID:
UI: 102242753
From Meeting Abstracts