Completed

Comparison of HIV-1 Derived Immunogens in Individuals with High CD4 Count for Prevention

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Study Aim

This study aims to compare the effectiveness of different HIV-1 derived immunogens in individuals with high CD4 count, as a preventive measure against HIV.

What is being tested

Aluminum hydroxide

+ MF59

+ rgp120/HIV-1IIIB

Biological
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

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

Prevention Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies. Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is seen among vaccine patients, then placebo patients may receive vaccination with one of the immunogens producing an immune response.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
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

130 patients to be enrolled

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

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

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 InfectionsAIDS-Related ComplexHIV Infections

Criteria

Inclusion Criteria Concurrent Medication: Allowed: Short-term nonsteroidal anti-inflammatory therapy. Patients must have: HIV seropositivity. CD4 count >= 500 cells/mm3. Successful establishment of EBV-transformed B-cell lines at study entry. Consent of parent or guardian if < 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Suspected or known allergies to any vaccine components. Medical contraindication. Problem with compliance. Concurrent Medication: Excluded: Antiretroviral therapy (e.g., AZT, ddI, or ddC). Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin). Parenteral therapies (including SC allergy sensitization). Other investigational HIV drugs or therapies. Prior Medication: Excluded: Any prior vaccinations against HIV. Antiretroviral therapy (e.g., AZT, ddI, or ddC) within the past 6 months. Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin) within the past 3 months. Parenteral therapies (including SC allergy sensitization) within the past 3 months. Other investigational HIV drugs or therapies within the past 3 months.

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

UCLA CARE Center CRS

Los Angeles, United StatesOpen UCLA CARE Center CRS in Google Maps

Stanford CRS

Palo Alto, United States

Santa Clara Valley Med. Ctr.

San Jose, United States

San Mateo County AIDS Program

San Mateo, United States
Completed10 Study Centers