Aboulker JP, Valentine CB, Tournerie C, Darbyshire JH; International Conference on AIDS.
Int Conf AIDS. 1991 Jun 16-21; 7: 206 (abstract no. W.B.2096).
MRC/INSERM Coordinating Committee and Collaborating Clinical Centres in the UK, Ireland, France, Australia, The Netherlands, Switzerland and Scandinavia
OBJECTIVE: To determine the efficacy and toxicity of didanosine (ddI) in patients with HIV disease intolerant of zidovudine. METHODS: Patients are randomised to either high-dose or low-dose didanosine or placebo (in all countries except France) in a double-blind design. If they are certain they wish to receive the drug they are randomised to the same two dose levels (in all countries). Comparisons will be based on survival, time to progression from ARC to AIDS or from AIDS to HIV encephalopathy, changes in CD4 cell counts and p24 antigen and serious adverse events. In addition a quantitative virological study is being undertaken in a sub-group of patients in France. RESULTS: Since May 1990 over 1200 patients have been enrolled, 16 of them to the placebo-controlled option. At randomisation 59% of patients had AIDS, 4% Kaposi's sarcoma, 35% ARC and 1% were asymptomatic. 78% had received more than 6 months of zidovudine. The reason for stopping was haematological in 69%, gastrointestinal in 6%, myopathy in 15% and other in 10%. There have been 134 deaths; in none was the drug clearly implicated. Progression from ARC (or KS) to AIDS has occurred in 47 patients and to HIV encephalopathy in 27. Trial drug has been stopped because of adverse events in 71 patients and interrupted or modified in 147; the commonest events were gastrointestinal(82) in particular diarrhoea and peripheral neuropathy (23) but this was not severe in any. Clinical pancreatitis occurred in 5 patients with a further 23 having large asymptomatic increases in amylase. DISCUSSION AND CONCLUSIONS: An independent Data and Safety Monitoring Committee regularly reviews the trial and a full interim analysis is planned when the first 500 patients have completed a median of 15 months follow-up. The large trial size means that moderate differences in efficacy and/or toxicity between the two dose levels can be detected.
Publication Types:
Keywords:
- AIDS Dementia Complex
- AIDS-Related Complex
- Acquired Immunodeficiency Syndrome
- CD4 Lymphocyte Count
- Clinical Trials Data Monitoring Committees
- Clinical Trials as Topic
- Didanosine
- Disease Progression
- Double-Blind Method
- France
- HIV Infections
- Humans
- Multicenter Study
- Zidovudine
Other ID:
UI: 102192678
From Meeting Abstracts