A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cells/mm3.

SECONDARY: To determine whether significant advantages to any one vaccine exist.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

130

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
        • UCLA CARE Center CRS
      • Palo Alto, California, United States, 94115
        • Stanford CRS
      • San Jose, California, United States, 951282699
        • Santa Clara Valley Med. Ctr.
      • San Mateo, California, United States, 943055107
        • San Mateo County AIDS Program
    • Colorado
      • Aurora, Colorado, United States, 80262
        • University of Colorado Hospital CRS
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital ACTG CRS
      • Boston, Massachusetts, United States, 02118
        • Bmc Actg Crs
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med. Ctr., ACTG CRS
    • New York
      • New York, New York, United States, 10016
        • NY Univ. HIV/AIDS CRS
    • Washington
      • Seattle, Washington, United States, 981224304
        • University of Washington AIDS CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Schooley RT
  • Study Chair: Walker B

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 7, 2022

Primary Completion

December 7, 2022

Study Completion (Actual)

September 1, 1996

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 214
  • 11191 (Registry Identifier: DAIDS ES Registry Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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