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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002347
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1995
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Saquinavir
Drug: Nevirapine
Drug: Zidovudine
Drug: Zalcitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 225
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002347

Locations
United States, Massachusetts
PAREXEL Intl Corp / InterCo Collaboration Ctr
Waltham, Massachusetts, United States, 02154
Sponsors and Collaborators
Parexel
  More Information

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)

ClinicalTrials.gov Identifier: NCT00002347     History of Changes
Other Study ID Numbers: 229C, ICC 001
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Zalcitabine
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Nevirapine
Saquinavir

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zalcitabine
Zidovudine
Nevirapine
Saquinavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014