Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)
- Conditions
- HIV Infections
- Registration Number
- NCT00000810
- Brief Summary
PRIMARY: To study the safety and tolerance of delavirdine mesylate ( U-90152 ) monotherapy. To compare the anti-HIV activity of three blood concentration levels of this agent with nucleoside analog monotherapy, either zidovudine ( AZT ) or didanosine ( ddI ), based on the reduction of HIV viral burden.
SECONDARY: To use pharmacokinetic parameters to assess the relationship between daily drug exposure and antiviral activity and toxicity of the U-90152, AZT, and ddI monotherapy. To assess anti-HIV activity using other disease markers.
Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors.
- Detailed Description
Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors.
Patients are randomized to receive U-90152 at one of three doses (treatment arms I through III) or either AZT or ddI (treatment arm IV). Patients on arm IV who are AZT-naive receive AZT; those who are AZT-experienced receive ddI. Treatment continues for 24 weeks.
PER 12/22/94 AMENDMENT: All patients receiving U-90152 have the same starting dose, to attain one of three target trough levels.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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 (10)
Howard University Hosp., Div. of Infectious Diseases, ACTU
🇺🇸Washington, District of Columbia, United States
Stanford CRS
🇺🇸Stanford, California, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States