Overview

Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Saquinavir
Zalcitabine
Zidovudine
Criteria
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.