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

Parexel

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Zalcitabine; Drug: Saquinavir; Drug: Nevirapine; Drug: Zidovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002347

ICC 001

229C

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.