Completed
Nevirapine and Zidovudine Combination for HIV-1 Infected Patients with Prior Zidovudine Therapy
What is being tested
Nevirapine
+ Zidovudine
Drug
Who is being recruted
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Over 13 Years
+70 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Summary
Principal SponsorBoehringer Ingelheim
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
In Part I, patients who have had prior AZT therapy receive either nevirapine or placebo in combination with AZT. In Part II, patients who are nucleoside naive receive either nevirapine or matching placebo. After 6 months, patients receive open-label nevirapine.
Principal SponsorBoehringer Ingelheim
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
250 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAIDS-Related ComplexHIV Infections
Criteria
12 inclusion criteria required to participate
Antifungal prophylaxis with oral fluconazole or ketoconazole
Antiviral prophylaxis for herpes simplex virus with <= 1000 mg/day oral acyclovir
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
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58 exclusion criteria prevent from participating
Antiretroviral medications other than AZT
Chronic use of alcohol or drugs sufficient to impair compliance with protocol requirements
Co-enrollment in a protocol involving another investigational drug or biologic
History of other clinically important disease (i.e., one that precludes participation in the study)
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 18 locations
Saint Francis Mem Hosp
San Francisco, United StatesWilmington Hosp
Wilmington, United StatesCommunity Research Initiative of South Florida
Coral Gables, United StatesCompleted18 Study Centers