Completed

Remune Treatment for HIV-1 Patients with Low CD4 Count

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
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
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

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 providing a treatment called Remune to adults infected with HIV-1, a virus that attacks the immune system. Specifically, it targets those individuals whose CD4 count, a measure of immune system health, is less than 300 cells/ml. The goal is to help these patients manage their condition better. This research is important because it aims to address the needs of HIV-infected individuals with lower CD4 counts, who may not have other effective treatment options. In this study, participants receive Remune as part of an expanded access program. This means they get the treatment outside of a traditional clinical trial. The treatment is given in an open-label format, meaning both the patients and their doctors know they are receiving Remune. The study doesn't measure specific outcomes, but it provides valuable access to this treatment for eligible patients.

NCT00002172
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 < 300 cells/ml
HIV-1 seropositivity
If a patient's CD4 count is 275 to 300 cells/ml, the patient must either rescreen 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

Immune Response Corp

Carlsbad, United StatesOpen Immune Response Corp in Google Maps
CompletedOne Study Center