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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nevirapine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Resistance, AIDS-Related Complex, Antiviral Agents, Nevirapine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients must have: Positive serum antibody to HIV-1 by ELISA or Western blot. CD4 count >= 500 cells/mm3 within 2 months prior to study entry, with two additional counts averaging >= 450 cells/mm3 at baseline and on study day 0 (taken at least 48 hours apart). No AIDS-defining disease. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: More than four loose stools per day. Participation in other experimental trials including vaccine trials. Concurrent Medication: Excluded: Other approved or investigational antiretroviral agents, other investigational agents, or vaccines. Glucocorticoids and steroid hormones. Dicumarol, warfarin, and other anticoagulants. Digitoxin. Valproic acid. Tolbutamide. Doxycycline. Chloramphenicol. Phenobarbital and other barbiturates. Excluded 4 hours before or after a nevirapine dose: Antacids (particularly those containing calcium carbonate). H-2 blockers, carafate, cholestyramine resin, alcohol and alcohol-containing substances, and benzodiazepines (e.g., diazepam, triazolam). Patients with the following prior conditions are excluded: History of clinically important disease other than HIV infection. Prior Medication: Excluded within 1 month prior to study entry: Any immunosuppressive, immunomodulatory, or cytotoxic treatment. Use of drugs or alcohol sufficient to impair compliance with protocol requirements.

Sites / Locations

  • UCSD

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
February 28, 2011
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00000747
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
December 1994 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Resistance, AIDS-Related Complex, Antiviral Agents, Nevirapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nevirapine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: Positive serum antibody to HIV-1 by ELISA or Western blot. CD4 count >= 500 cells/mm3 within 2 months prior to study entry, with two additional counts averaging >= 450 cells/mm3 at baseline and on study day 0 (taken at least 48 hours apart). No AIDS-defining disease. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: More than four loose stools per day. Participation in other experimental trials including vaccine trials. Concurrent Medication: Excluded: Other approved or investigational antiretroviral agents, other investigational agents, or vaccines. Glucocorticoids and steroid hormones. Dicumarol, warfarin, and other anticoagulants. Digitoxin. Valproic acid. Tolbutamide. Doxycycline. Chloramphenicol. Phenobarbital and other barbiturates. Excluded 4 hours before or after a nevirapine dose: Antacids (particularly those containing calcium carbonate). H-2 blockers, carafate, cholestyramine resin, alcohol and alcohol-containing substances, and benzodiazepines (e.g., diazepam, triazolam). Patients with the following prior conditions are excluded: History of clinically important disease other than HIV infection. Prior Medication: Excluded within 1 month prior to study entry: Any immunosuppressive, immunomodulatory, or cytotoxic treatment. Use of drugs or alcohol sufficient to impair compliance with protocol requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richman D
Official's Role
Study Chair
Facility Information:
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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PubMed Identifier
7594683
Citation
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. doi: 10.1093/infdis/172.5.1379.
Results Reference
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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

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