Expired Study
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San Diego, California


Purpose:

To determine the safety and anti-HIV activity of delavirdine mesylate ( U-90152 ) in combination with zidovudine ( AZT ) and/or didanosine ( ddI ) versus AZT/ddI combination. U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.


Study summary:

U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease. Patients are randomized to receive U-90152/AZT/ddI, U-90152/AZT, U-90152/ddI, or AZT/ddI for 48 weeks.


Criteria:

Inclusion Criteria Concurrent Medication: Required: - PCP prophylaxis for patients with CD4 count <= 200 cells/mm3. Allowed: - Topical antifungal agents. - Oral ketoconazole, fluconazole, and itraconazole for candidiasis or disseminated fungal infections. - Isoniazid, ethambutol, pyrazinamide, clofazimine, ciprofloxacin, and clarithromycin for acute or maintenance therapy for mycobacterial disease (also clarithromycin for MAC prophylaxis). - Acute or maintenance therapy for toxoplasmosis. - Acute or maintenance therapy with acyclovir (no more than 1000 mg/day) for herpes simplex virus infection. - rEPO and rG-CSF. - Antibiotics for bacterial infections (except rifampin and rifabutin). - Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone. Concurrent Treatment: Allowed for cutaneous Kaposi's sarcoma: - Localized radiation therapy. - Limited intralesional therapy. Patients must have: - HIV infection. - CD4 count 100 - 500 cells/mm3. - Prior cumulative monotherapy of <= 6 months (may have taken either AZT or ddI, but not both) OR no prior antiretroviral therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Malignancy (other than basal or squamous cell carcinoma of the skin, Stage 1 or 2 cervical intraepithelial neoplasia, or minimal Kaposi's sarcoma). - Considered to be unlikely to comply with study requirements. Concurrent Medication: Excluded: - Antiretroviral therapies and biologic response modifiers (except for study medications, rEPO, and rG-CSF). - Rifampin. - Rifabutin. - Terfenadine. - Astemizole. - Loratadine. - Quinidine. - Digitoxin. - Systemic corticosteroids for more than 21 consecutive days. - Foscarnet. - Systemic cytotoxic chemotherapy for a malignancy. Patients with the following prior conditions are excluded: - History of intolerance to AZT at <= 600 mg/day or ddI at <= 400 mg/day or discontinuation of either drug for toxicity. - History of intolerance to trifluoperazine or piperazine citrate (per amendment). - History of pancreatitis. - History of grade 2 or worse peripheral neuropathy. - Unexplained temperature >= 38.5 C on any 7 days within the past 30 days. - Chronic diarrhea on any 15 days during the past 30 days. Prior Medication: Excluded: - Prior foscarnet as induction or maintenance therapy. - Prior U-90152. - Prior ddC or d4T. - Prior AZT/ddI in combination or taken separately at different times. - Prior non-nucleoside reverse transcriptase inhibitors (nevirapine, atevirdine, etc.). - Prior protease inhibitors (although patients from ACTG 282 are eligible). - HIV-1 vaccine within the past 21 days. - Acute treatment for a serious infection or for any opportunistic infection within the past 14 days. Excluded within the past 30 days: - Interferon or interleukin. - Rifampin. - Rifabutin. - Terfenadine. - Astemizole. - Loratadine. - Recombinant EPO or G-CSF. - Hydroxyurea. - SPV-30. - Any other investigational drug. Active drug or alcohol use.


NCT ID:

NCT00000803


Primary Contact:

Study Chair
Friedland G


Backup Contact:

N/A


Location Contact:

San Diego, California
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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