Trials / Completed
CompletedNCT00001989
A Randomized Phase II Efficacy, Activity and Safety Study of GLQ223 Alone and in Combination With Zidovudine in Symptomatic HIV-Infected Patients Without Prior Treatment With GLQ223 or Trichosanthin
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Genelabs Technologies · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study involves GLQ223 administration to patients who have not previously been exposed to it, but who have received at least 9 months of zidovudine therapy. Efficacy evaluations will include survival, opportunistic infections, T4 cell count, and assessments of viral load.
Detailed description
The study will involve the randomization of patients with 200-500 T4 cells and AIDS or ARC to one of three treatment arms: zidovudine alone, GLQ223 alone, or GLQ223 plus zidovudine. Patients randomized to receive GLQ223 will receive an infusion every three weeks for 45 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trichosanthin | |
| DRUG | Zidovudine |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00001989. Inclusion in this directory is not an endorsement.