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

NCT ID: NCT00002347

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL

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.

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.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Saquinavir

Intervention Type: DRUG

Nevirapine

Intervention Type: DRUG

Zidovudine

Intervention Type: DRUG

Zalcitabine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: lead

Locations

PAREXEL Intl Corp / InterCo Collaboration Ctr

Waltham, Massachusetts, United States

Countries

United States

References

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)

Reference Type: BACKGROUND

Other Identifiers

ICC 001

Identifier Type: -

Identifier Source: secondary_id

229C

Identifier Type: -

Identifier Source: org_study_id