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