Completed
HIV-1 Immunogen's Effect on AIDS-Free Survival in HIV-Infected Patients with CD4 T-Lymphocytes Between 300 and 549 Cells/microL
What is being tested
HIV-1 Immunogen
Biological
Who is being recruted
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+13 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Summary
Principal SponsorThe Immune Response Corporation
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients receive 10 units of HIV-1 immunogen in IFA or IFA alone every 12 weeks, then are followed for 104-148 weeks.
Principal SponsorThe Immune Response Corporation
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
3000 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 InfectionsAIDS-Related ComplexHIV Infections
Criteria
6 inclusion criteria required to participate
Allowed: Antiretrovirals if on a stable dose for at least the past 3 months
Allowed: Prior antiretrovirals
Been on a stable dose of antiretroviral for the past 3 months, if taking antiretrovirals
HIV-1 infection with CD4 count 300-549 cells/mm3
Show More Criteria
7 exclusion criteria prevent from participating
Active substance abuse
Acute infection requiring prescription therapy within the past month, other than genital herpes and oral or vaginal candidiasis
History of any illness that would interfere with study
Prior HIV-1 Immunogen
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 54 locations
Ctr for Special Immunology
Irvine, United StatesJeffrey Goodman Special Care Clinic
Los Angeles, United StatesKraus Med Partners
Los Angeles, United StatesCompleted54 Study Centers