Completed
Ro 31-8959 and HIVID Combination for Advanced HIV Infection
What is being tested
Saquinavir
+ Zalcitabine
Drug
Who is being recruted
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+27 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Summary
Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients are randomized to one of three treatment regimens: ddC alone, Ro 31-8959 alone, and ddC plus Ro 31-8959. Treatment continues for at least 48 weeks. Patients are stratified by baseline CD4 count. (Per 09/26/94 amendment, a fourth arm, lower dose Ro 31-8959 plus ddC, was discontinued.)
Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
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
900 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 18 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
7 inclusion criteria required to participate
CD4 count 50 - 300 cells/mm3
Documented HIV infection
G-CSF and erythropoietin allowed
Limited localized radiation therapy to the skin allowed
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20 exclusion criteria prevent from participating
Acute therapy for opportunistic infection within 14 days prior to study entry
Antineoplastic agents
Any grade 3 or worse laboratory or clinical abnormality
Biologic response modifiers
Show More Criteria
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 47 locations
UCSD
La Jolla, United StatesUCLA School of Medicine
Los Angeles, United StatesCARE Ctr / UCLA Med Ctr
Los Angeles, United StatesCompleted47 Study Centers