Trials / Completed
CompletedNCT00002033
A Third-Party Blinded, Placebo Controlled Comparative Study of AS-101 Administered Intravenously in HIV Positive Patients With Advanced Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 13 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zidovudine | |
| DRUG | AS-101 |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
4 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT00002033. Inclusion in this directory is not an endorsement.