Cameron DW, Heath-Chiozzi M, Kravcik S, Mills R, Potthoff A, Henry D; International Conference on AIDS.
Int Conf AIDS. 1996 Jul 7-12; 11: 24 (abstract no. Mo.B.411).
Ottawa General Hospital, Ottawa, Ontario, Canada. Fax: 613-737-8682. E-mail: bcameron@aixl.uottawa.ca.
Objective: Ritonavir is a potent, orally bioavailable HIV protease inhibitor. We designed and conducted an international multi-centre randomized placebo-controlled clinical trial of ritonavir 600 mg twice daily for outcomes of death and new AIDS-defining illnesses or selected recurrences (pneumocystis pneumonia, esophageal candidiasis, and chronic herpetic ulcer). Methods: 1090 HIV patients with CD4 T lymphocyte count under 101 cells/mm3 and over nine months prior anti-HIV therapy were randomized in 68 North American, European and Australian centres, from April to July 1995. Concurrent anti-HIV therapy was permitted. Crossover to open ritonavir for any AIDS outcome was provided after four months on study. Final analysis was conducted in January 1996. Results: Baseline characteristics did not differ, with median CD4 T cells 18/mm3 (mean 30, standard deviation 28) in ritonavir and 22/mm3 (mean 35, standard deviation 28) in placebo groups. Drug discontinuation associated with adverse events occurred in 91 (17%) of 543 ritonavir, versus 32 (6%) of 547 placebo patients. Events included nausea, vomiting, weakness and diarrhea mostly beginning during the first two weeks on study. In median 6.1 (range 0.2 to 7.7) months follow-up, 26 (4.8%) ritonavir versus 46 (8.4%) placebo patients died (p=0.02, hazard ratio 0.57, 95% CI 0.35 - 0.92). Outcomes of either AIDS or death occurred in 85 (15.7%) versus 181 (33.1%, p is less than 0.001, hazard ratio 0.44, 95% CI 0.34-0.56). Stratified analyses show increased ritonavir effect with concomitant anti-HIV drug treatment. Conclusion: This study shows that ritonavir therapy in advanced HIV immunodeficiency prevents AIDS complications and prolongs life. Ritonavir treatment may be more beneficial as combination anti-HIV therapy. This study was presented in part at the 3rd Conference on Retroviruses and Opportunistic Infections.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- Antigens, CD4
- CD4 Lymphocyte Count
- CD4-Positive T-Lymphocytes
- Disease Progression
- Drug Therapy, Combination
- HIV Infections
- HIV Protease Inhibitors
- HIV Seropositivity
- Humans
- Ritonavir
- drug therapy
- immunology
- therapy
Other ID:
UI: 102216825
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