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Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC
Not Recruiting
Trial ID: NCT00001040
Purpose
PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir
mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC)
vs. Ro 31-8959 plus AZT plus ddC.
SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of
the three regimens.
Official Title
Double-Blind, Randomized, Phase II Study of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus Ro 31-8959 Plus AZT Plus ddC
Eligibility
Inclusion Criteria
Prior Medication: Required:
- At least 4 months total of AZT at some point in the past, alone or in combination with
other antiretroviral therapy.
Patients must have:
- HIV seropositivity.
- Diagnosis of AIDS, ARC, PGL, or asymptomatic infection.
- CD4 count > 50 to <= 300 cells/mm3.
- Life expectancy of at least 6 months.
- Prior AZT therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Acute serious opportunistic infections requiring immediate treatment, including (but
not limited to) tuberculosis, CMV, cryptococcal meningitis, disseminated MAC, cerebral
toxoplasmosis, and Pneumocystis carinii pneumonia.
- Known intolerance to Ro 31-8959, AZT, or ddC.
- Symptoms suggestive of pancreatitis.
- Moderate or severe peripheral neuropathy as evidenced by discomfort from numbness,
tingling, burning or pain of the extremities or any related symptoms that are
accompanied by an objective finding.
- Visceral Kaposi's sarcoma.
- Lymphoma that will require therapy within the next 6 months.
- Transfusion dependence.
Concurrent Medication:
Excluded:
- Investigational or antineoplastic agents.
Concurrent Treatment:
Excluded:
- Radiotherapy (other than local skin radiotherapy).
- Transfusions.
Prior Medication:
Excluded:
- Any antiretroviral agent (other than AZT) or immunomodulatory therapy within 14 days
prior to study entry.
- Prior treatment with an HIV proteinase inhibitor.
Intervention(s):
drug: Saquinavir
drug: Zidovudine
drug: Zalcitabine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305