Completed
Remune (HIV-1 Immunogen) for HIV-Infected Adults with High CD4 Count
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
Interventional
Summary
Principal SponsorThe Immune Response Corporation
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on HIV-infected adults who have a CD4 count of 550 cells/ml or greater. The main goal is to offer an alternative therapy, Remune (HIV-1 Immunogen), to those for whom current drugs or therapies are not suitable or comparable. The importance of this study lies in its potential to provide a new treatment option for HIV patients, addressing an unmet need in HIV care.
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.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 SyndromeHIV Infections
Criteria
6 inclusion criteria required to participate
CD4 counts >= 550 cells/ml
HIV-1 seropositivity
If a patient's CD4 count is 550 to 600 cells/ml, the patient must either rescreen within 30 days for Study 806 or wait 6 months before entering the expanded access program
Patient must have failed or been intolerant to other comparable or alternative marketed therapies or must not be a candidate for such therapies
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7 exclusion criteria prevent from participating
Clinically significant cardiac, hepatic, renal or gastrointestinal dysfunction
Current participation in a Remune study
Induction therapy or initiation of new treatment regimen for an AIDS-defining condition
Induction therapy or initiation of new treatment regimen for an AIDS-defining condition within 30 days of Day 1 visit
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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 1 location
CompletedOne Study Center