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
- Conditions
- HIV Infections
- Registration Number
- NCT00001989
- Lead Sponsor
- Genelabs Technologies
- Brief 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.
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 (8)
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Miami Veterans Administration Med Ctr
🇺🇸Miami, Florida, United States
Dr Larry A Waites
🇺🇸San Francisco, California, United States
Saint Francis Mem Hosp
🇺🇸San Francisco, California, United States
Saint Vincent's Hosp and Med Ctr
🇺🇸New York, New York, United States
Northwestern Univ
🇺🇸Chicago, Illinois, United States
Infectious Disease Research Institute Inc
🇺🇸Tampa, Florida, United States
ViRx Inc
🇺🇸San Francisco, California, United States