Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Saquinavir

+ Zidovudine

+ Zalcitabine

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: March 1, 2011
Sourced from a government-validated database.Claim as a partner

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.

NCT00001040
Principal SponsorHoffmann-La Roche
Last updated: March 1, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

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 Maps

Stanford Univ Med Ctr

Stanford, United States

Univ of Colorado Health Sciences Ctr

Denver, United States

Northwestern Univ Med School

Chicago, United States
Completed10 Study Centers