Expired Study
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Waltham, Massachusetts 02154


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.


Study summary:

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.


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.


NCT ID:

NCT00002347


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Waltham, Massachusetts 02154
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 22, 2017

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