Expired Study
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Washington, District of Columbia 20037


To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.

Study summary:

Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.


Inclusion Criteria Concurrent Medication: Allowed: - Erythropoietin and G-CSF. Concurrent Treatment: Allowed: - Local skin radiotherapy. Patients must have: - HIV infection. - CD4 count 50 - 350 cells/mm3. - No prior antiretroviral therapy OR less than 16 weeks of prior AZT. - No acute serious opportunistic infections requiring immediate treatment. - No unexplained fever persisting for 14 days within 90 days prior to study entry. - No significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry. - No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy. - Life expectancy of at least 80 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Malabsorption. - Severe chronic diarrhea. - Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort). - Any grade 3 or worse toxicity. - Inability to comply with study requirements. Concurrent Medication: Excluded: - Other investigational agents. - Antineoplastic agents. - Biologic response modifiers (including interferons). - Foscarnet. - Anti-HIV drugs other than the study drugs. Concurrent Treatment: Excluded: - Radiotherapy (other than local skin radiotherapy). Patients with the following prior condition are excluded: History of non-Hodgkin's lymphoma. Prior Medication: Excluded: - Acute therapy for opportunistic infection within 14 days prior to study entry. - Prior HIV proteinase inhibitor.



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Backup Contact:


Location Contact:

Washington, District of Columbia 20037
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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