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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000747 |
Primary: To evaluate the rate of development of resistance to nevirapine in HIV-1 infected individuals. To evaluate safety of nevirapine in HIV-1 infected individuals with CD4 counts greater than or equal to 500 cells/mm3.
Secondary: To evaluate the effect of nevirapine on surrogate markers. The anti-HIV agent nevirapine is associated with rapid emergence of resistance when administered alone or in combination with zidovudine to HIV-infected patients with CD4 counts <= 400 cells/mm3. In persons with less advanced HIV disease and less viral burden, the emergence of resistance may be delayed, thus permitting evaluation for beneficial effect in a population where there is currently no established therapy.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Nevirapine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Pharmacokinetics Study |
Official Title: | An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3 |
Estimated Enrollment: | 10 |
The anti-HIV agent nevirapine is associated with rapid emergence of resistance when administered alone or in combination with zidovudine to HIV-infected patients with CD4 counts <= 400 cells/mm3. In persons with less advanced HIV disease and less viral burden, the emergence of resistance may be delayed, thus permitting evaluation for beneficial effect in a population where there is currently no established therapy.
Ten patients receive nevirapine daily for 12 weeks. After 12 weeks of therapy, patients in whom resistance was not evident at week 4 and who have an adequate safety profile continue receiving nevirapine for an additional 12 weeks. Clinical and immunological assessments are performed at weeks 4, 8, 12, 16, 20, and 24. Virological assessments are performed at week 24 only. If 50 percent of patients develop resistance at any time, the study is discontinued.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Excluded 4 hours before or after a nevirapine dose:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded within 1 month prior to study entry:
Use of drugs or alcohol sufficient to impair compliance with protocol requirements.
Study ID Numbers: | ACTG 208, BI 00947 |
Study First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00000747 |
Health Authority: | United States: Federal Government |
Drug Resistance AIDS-Related Complex Antiviral Agents Nevirapine |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |