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

• ClinicalTrials.gov Identifier: NCT00002347
• Recruitment Status: Completed
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Sponsor: Parexel
• Information provided by: NIH AIDS Clinical Trials Information Service

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
HIV Infections	Drug: Saquinavir; Drug: Nevirapine; Drug: Zidovudine; Drug: Zalcitabine	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 225 participants
• Masking: Double
• 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

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 13 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: 229C; ICC 001
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Last Verified: June 1995

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:

Infection; Communicable Diseases; 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; Zidovudine; Nevirapine; Zalcitabine; Saquinavir; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Anti-HIV Agents; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 Enzyme Inducers; HIV Protease Inhibitors; Protease Inhibitors