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
Saquinavir
+ Zidovudine
+ Zalcitabine
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
Univ of Alabama at Birmingham
Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google MapsStanford Univ Med Ctr
Stanford, United StatesUniv of Colorado Health Sciences Ctr
Denver, United StatesNorthwestern Univ Med School
Chicago, United States