A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell

June 23, 2005 updated by: Boehringer Ingelheim

A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cells/mm3

PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage.

SECONDARY: To compare and evaluate other markers of immunologic and virologic activity in patients receiving nevirapine/AZT versus AZT alone. To compare the effects of the two regimens on clinical signs and symptoms. To evaluate the safety and tolerance of the two regimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients receive combination nevirapine/AZT or AZT alone. Patients are evaluated for virologic and immunologic activity at 3 and 6 months.

Study Type

Interventional

Enrollment

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 946021018
        • Highland Gen Hosp / San Francisco Gen Hosp
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hosp
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Washington Univ School of Medicine
    • Texas
      • Galveston, Texas, United States, 775550882
        • Univ TX Galveston Med Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • PCP prophylaxis (trimethoprim-sulfamethoxazole, dapsone, or aerosolized pentamidine), at the discretion of the investigator.
  • Antifungal prophylaxis with oral fluconazole or ketoconazole.
  • Antiviral prophylaxis for herpes simplex virus with <= 1000 mg/day oral acyclovir.
  • Dilantin for prevention and treatment of seizures.

Patients must have:

  • Asymptomatic HIV infection.
  • CD4 count 200-500 cells/mm3.
  • No prior AIDS.
  • No history of or active HIV-related thrush, vaginal candidiasis, zoster (shingles), excessive weight loss, persistent fever, or diarrhea.
  • Tolerated 500-600 mg AZT daily for at least 4 months but no more than 12 months immediately prior to study entry.
  • Consent of parent or guardian if less than 18 years of age.

NOTE:

  • Patients may not co-enroll in another protocol involving other investigational drugs or biologics.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Malignancy other than limited cutaneous basal cell carcinoma.
  • Psychiatric condition sufficient to impair study compliance.

Concurrent Medication:

Excluded:

  • Systemic glucocorticoids and steroid hormones.
  • Dicumarol, warfarin, and other anticoagulant medications.
  • Cimetidine.
  • Tolbutamide.
  • Doxycycline.
  • Chloramphenicol.
  • Phenobarbital and other barbiturates.
  • Foscarnet.
  • Erythromycin.
  • Amoxicillin-clavulanate (Augmentin).
  • Ticarcillin clavulanate.
  • Biologic response modifiers (alpha interferon, IL-2, immune modulators).
  • Any investigational drugs other than study drugs.

Patients with the following prior condition are excluded:

History of clinically important disease other than HIV infection, that may put patient at risk because of participation in this study.

Prior Medication:

Excluded:

  • Antiretroviral medications other than AZT.

Excluded within 4 weeks prior to study entry:

  • Immunosuppressive or cytotoxic drugs or other experimental drugs.
  • Systemic glucocorticoids and steroid hormones.
  • Dicumarol, warfarin, and other anticoagulant medications.
  • Cimetidine.
  • Tolbutamide.
  • Doxycycline.
  • Chloramphenicol.
  • Phenobarbital and other barbiturates.
  • Foscarnet.
  • Erythromycin.
  • Amoxicillin-clavulanate (augmentin).
  • Ticarcillin clavulanate.
  • Biologic response modifiers (alpha interferon, IL-2, immune modulators).

Required:

  • AZT at 500-600 mg/day for at least 4 months but no more than 12 months immediately preceding study entry.

Chronic use of alcohol or drugs sufficient to impair study compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

August 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200B
  • BIPI 1037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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