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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Boehringer Ingelheim Pharmaceuticals |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000747 |
Purpose
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 |
|
HIV Infections |
Drug: Nevirapine |
Phase II |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Nevirapine |
| 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.
Eligibility
| 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.
Contacts and Locations| United States, California | |||||
| UCSD | |||||
| San Diego, California, United States, 92103 | |||||
| National Institute of Allergy and Infectious Diseases (NIAID) |
| Boehringer Ingelheim Pharmaceuticals |
| Study Chair: | Richman D |
More Information
Click here for more information about Nevirapine 
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Havlir D. An open-label pilot study to evaluate the development of resistance to nevirapine (BI-RG-587) in HIV-infected patients with CD4 cell count > or = 500/mm. ACTG 208 Study Team. Int Conf AIDS. 1993 Jun 6-11;9(1):470 (abstract no PO-B26-2009)
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Havlir D, McLaughlin MM, Richman DD. A pilot study to evaluate the development of resistance to nevirapine in asymptomatic human immunodeficiency virus-infected patients with CD4 cell counts of > 500/mm3: AIDS Clinical Trials Group Protocol 208. J Infect Dis. 1995 Nov;172(5):1379-83.
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| Study ID Numbers: | ACTG 208, BI 00947 |
| First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000747 |
| Health Authority: | United States: Federal Government |
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