Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002324 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Nevirapine Drug: Zidovudine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 250 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following condition are excluded:
History of other clinically important disease (i.e., one that precludes participation in the study).
Prior Medication:
Excluded:
Excluded within 4 weeks prior to study entry:
Required (for patients in Part I):
United States, California | |
Saint Francis Mem Hosp | |
San Francisco, California, United States, 94109 | |
UCSD Treatment Ctr | |
San Diego, California, United States, 92103 | |
United States, Delaware | |
Wilmington Hosp | |
Wilmington, Delaware, United States, 19801 | |
United States, Florida | |
Community Research Initiative of South Florida | |
Coral Gables, Florida, United States, 33146 | |
Goodgame Med Group | |
Maitland, Florida, United States, 32751 | |
United States, Kansas | |
Univ of Kansas School of Medicine | |
Wichita, Kansas, United States, 67214 | |
United States, Kentucky | |
Chandler Med Ctr | |
Lexington, Kentucky, United States, 405360084 | |
United States, Missouri | |
Kansas City AIDS Research Consortium | |
Kansas City, Missouri, United States, 641082792 | |
United States, New York | |
Community Research Initiative on AIDS | |
New York, New York, United States, 10001 | |
United States, Ohio | |
Med College of Ohio | |
Toledo, Ohio, United States, 43699 | |
United States, Oklahoma | |
Associates Med and Mental Health | |
Tulsa, Oklahoma, United States, 74114 | |
United States, Pennsylvania | |
Philadelphia FIGHT | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, South Carolina | |
Dr Alfred F Burnside Jr | |
Columbia, South Carolina, United States, 29204 | |
United States, Texas | |
Houston Clinical Research Network | |
Houston, Texas, United States, 77006 | |
Nelson-Tebedo Community Clinic | |
Dallas, Texas, United States, 75219 | |
United States, Utah | |
Univ of Utah School of Medicine | |
Salt Lake City, Utah, United States, 84132 | |
United States, Virginia | |
Infectious Disease Physicians Inc | |
Annandale, Virginia, United States, 22203 | |
Richmond AIDS Consortium | |
Richmond, Virginia, United States, 23219 |
Study ID Numbers: | 200C, 1038 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002324 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Drug Therapy, Combination AIDS-Related Complex Zidovudine Nevirapine |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Zidovudine AIDS-Related Complex Antiviral Agents |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Nevirapine Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Nevirapine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |