The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease
A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Activity, Safety, and Tolerance of 1) 400 Mg Nevirapine in Combination With 500-600 Mg Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 3-24 Months of Prior Zidovudine Therapy and 200-500 CD4 Cells/mm3 and 2) 400 Mg Nevirapine Versus Nevirapine Placebo in Asymptomatic HIV-1 Nucleoside Naive Patients With 200-500 CD4 Cells/mm3
2 other identifiers
interventional
250
1 country
18
Brief Summary
PRIMARY: To compare the effect of nevirapine versus placebo alone or in combination with zidovudine (AZT) on CD4 T-cell count and percentage after 3 and 6 months of treatment. To evaluate the safety and tolerance of nevirapine alone or in combination with AZT. SECONDARY: To compare the effects of the various treatment combinations on virologic and immunologic markers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
August 1, 2002
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- PCP prophylaxis (trimethoprim-sulfamethoxazole, dapsone, or aerosolized pentamidine), at the discretion of the investigator.
- Antifungal prophylaxis with oral fluconazole or ketoconazole.
- Antiviral prophylaxis for herpes simplex virus with \<= 1000 mg/day oral acyclovir.
- Dilantin for prevention and treatment of seizures.
- Patients must have:
- Asymptomatic HIV-1 infection, with positive serum antibody to HIV-1 as determined by ELISA or Western blot.
- CD4 count 200-500 cells/mm3 within 4-28 days prior to study entry.
- No conditions indicative of AIDS.
- None of the constitutional symptoms that are specifically excluded.
- Prior AZT for 3-24 months (amended 04/04/94) immediately prior to study entry (Part I) OR no prior AZT (Part II).
- Consent of parent or guardian if less than 18 years of age.
- NOTE:
- Co-enrollment in a protocol involving another investigational drug or biologic is not permitted.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Malignancy other than limited cutaneous basal cell carcinoma.
- Psychiatric condition sufficient to impair compliance with protocol requirements.
- Concurrent Medication:
- Excluded:
- Investigational drugs other than study drugs.
- Systemic glucocorticoids and steroid hormones.
- Dicumarol, warfarin, and other anticoagulant medications.
- Cimetidine.
- Tolbutamide.
- Doxycycline.
- Chloramphenicol.
- Phenobarbital and other barbiturates.
- Foscarnet.
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
UCSD Treatment Ctr
San Diego, California, 92103, United States
Saint Francis Mem Hosp
San Francisco, California, 94109, United States
Wilmington Hosp
Wilmington, Delaware, 19801, United States
Community Research Initiative of South Florida
Coral Gables, Florida, 33146, United States
Goodgame Med Group
Maitland, Florida, 32751, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214, United States
Chandler Med Ctr
Lexington, Kentucky, 405360084, United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, 641082792, United States
Community Research Initiative on AIDS
New York, New York, 10001, United States
Med College of Ohio
Toledo, Ohio, 43699, United States
Associates Med and Mental Health
Tulsa, Oklahoma, 74114, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Dr Alfred F Burnside Jr
Columbia, South Carolina, 29204, United States
Nelson-Tebedo Community Clinic
Dallas, Texas, 75219, United States
Houston Clinical Research Network
Houston, Texas, 77006, United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
Richmond AIDS Consortium
Richmond, Virginia, 23219, United States
Related Publications (1)
Pollard R . Surrogate marker response to NVP/ZDV or ZDV in a blinded clinical trial: correlation to changes in HIV isolate phenotypic susceptibility to NVP and ZDV. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:113
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2002-08