The Safety and Effectiveness of Retrovir Plus HIVID Combined With Either Nevirapine or Invirase in the Treatment of HIV Infection

June 23, 2005 updated by: Parexel

A Master Protocol to Evaluate the Safety and Efficacy of Multi-Drug Combination Antiretroviral Therapy for the Treatment of HIV Infection: Retrovir/HIVID/Nevirapine and Retrovir/HIVID/Invirase

To evaluate the tolerance and immunologic and virologic effects of multidrug combinations of antiretrovirals in patients with HIV infection. Specifically, to evaluate zidovudine/zalcitabine ( AZT / ddC ) alone or in combination with either nevirapine or saquinavir ( Ro 31-8959 ).

Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available.

Patients are randomized to receive AZT/ddC either alone or in combination with nevirapine or Ro 31-8959 for a minimum of 48 weeks. Patients are followed at weeks 2 and 4 and every 4 weeks thereafter.

Study Type

Interventional

Enrollment

225

Phase

  • Phase 2

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
    • Massachusetts
      • Waltham, Massachusetts, United States, 02154
        • PAREXEL Intl Corp / InterCo Collaboration Ctr

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 (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Encouraged:

  • PCP chemoprophylaxis for patients whose CD4 count falls below 200 cells/mm3 or who develop PCP on study.

Allowed:

  • Secondary prophylaxis with nonexperimental agents in patients who develop TB, Mycobacterium avium-intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection.
  • Acyclovir for 21 days or less for acute treatment.
  • Recombinant erythropoietin and G-CSF for grade 3 or worse anemia and neutropenia, respectively.

Patients must have:

  • HIV infection.
  • CD4 count 200 - 500 cells/mm3.
  • No prior antiretroviral therapy.
  • Life expectancy of at least 48 weeks.
  • Consent of parent or guardian if less than 18 years of age.

NOTE:

  • Participating centers are encouraged to enroll female patients.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Any grade 3 or greater toxicity.
  • Symptoms of peripheral neuropathy.
  • Malabsorption or severe chronic diarrhea.
  • Inability to eat at least one meal daily because of chronic nausea, emesis, or abdominal or esophageal discomfort.

Concurrent Medication:

Excluded during the first 28 days of nevirapine administration:

  • Augmentin and other antibiotics containing clavulanic acid.

Excluded at any time:

  • Dicumarol, warfarin, and other anticoagulant medications.
  • Tolbutamide.
  • Cimetidine.
  • Erythromycin.

Patients with the following prior conditions are excluded:

  • History of acute or chronic pancreatitis.
  • History of grade 2 or worse peripheral neuropathy from any cause.

Prior Medication:

Excluded:

  • Any prior antiretroviral therapy.

Excluded within 4 weeks prior to study entry:

  • Immunomodulating agents such as systemic corticosteroids, IL-2, alpha-interferon, beta-interferon, or gamma-interferon.
  • Immunotherapeutic vaccines.
  • Cytotoxic chemotherapy.
  • Erythromycin.
  • Dicumarol, Coumadin / warfarin, and other anticoagulant medications.
  • Phenobarbital.
  • Amoxicillin / clavulanate.
  • Ticarcillin / clavulanate.
  • Tolbutamide.
  • Erythromycin.
  • Cimetidine.

Prior Treatment:

Excluded within 4 weeks prior to study entry:

  • Non-local radiation therapy. Current alcohol or illicit drug use that would interfere with ability to comply with study requirements.

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

Parexel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Thompson M, Myers M, Salgo M, Rousseau F, Odorisio M, Warburg M. A master protocol to evaluate the safety and efficacy of multidrug combination antiretroviral therapy with zidovudine and zalcitabine with or without saquinavir or nevirapine for the treatment of HIV infection. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:109 (abstract no 242)

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

June 1, 1995

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 229C
  • ICC 001

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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