A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell
2 other identifiers
interventional
60
1 country
5
Brief Summary
PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage. SECONDARY: To compare and evaluate other markers of immunologic and virologic activity in patients receiving nevirapine/AZT versus AZT alone. To compare the effects of the two regimens on clinical signs and symptoms. To evaluate the safety and tolerance of the two regimens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
5 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 infection.
- CD4 count 200-500 cells/mm3.
- No prior AIDS.
- No history of or active HIV-related thrush, vaginal candidiasis, zoster (shingles), excessive weight loss, persistent fever, or diarrhea.
- Tolerated 500-600 mg AZT daily for at least 4 months but no more than 12 months immediately prior to study entry.
- Consent of parent or guardian if less than 18 years of age.
- NOTE:
- Patients may not co-enroll in another protocol involving other investigational drugs or biologics.
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 study compliance.
- Concurrent Medication:
- Excluded:
- Systemic glucocorticoids and steroid hormones.
- Dicumarol, warfarin, and other anticoagulant medications.
- Cimetidine.
- Tolbutamide.
- Doxycycline.
- Chloramphenicol.
- Phenobarbital and other barbiturates.
- Foscarnet.
- Erythromycin.
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Washington Univ School of Medicine
St Louis, Missouri, 63108, United States
Univ TX Galveston Med Branch
Galveston, Texas, 775550882, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- 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