A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease
- Conditions
- HIV Infections
- Registration Number
- NCT00002033
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
To compare the effect of AS-101 to that of placebo on clinical efficacy and immunologic function in HIV positive patients with advanced disease. To compare the effect of AS-101 to that of placebo on occurrence of disease progression in HIV positive patients with advanced disease as defined by: (1) development of new diagnostically confirmed major opportunistic infection(s); or (2) development of AIDS-related dementia. To compare the effect of zidovudine (AZT) plus AS-101 versus AZT alone (placebo arm) on clinical efficacy and immunologic function in patients who require anti-viral therapy due to disease progression. Garlic capsules will be given to all study participants to mask the obvious garlic odor of AS-101.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Instituto Do Cancer Arnaldo Vieiro
🇧🇷Sao Paulo, Brazil
Escola Paulista De-Medicina
🇧🇷Sao Paulo, Brazil
Faculdade De-Ciencias Medica Da
🇧🇷Sao Paulo, Brazil
Hosp De-Servidor Publico Estadual
🇧🇷Sao Paulo, Brazil