Effects of Immunization With HIV-1 Immunogen Plus Anti-HIV Treatment Interruption on the Levels of HIV

NCT00021762 | Withdrawn Phase 2

• 4 other identifiers: A512010938ACTG A5120AACTG A5120
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to see whether or not an HIV vaccination will help the body control the amount of HIV virus in blood (viral load) in patients who are not taking anti-HIV medicines. Doctors are not sure why the body fails to control HIV viral load in most people infected with HIV. The vaccine Remune has been shown to boost part of the body's immune response to HIV in patients whose viral load has been lowered with anti-HIV drugs. This study will test the ability of Remune to improve the body's immune response and to lower HIV viral load in patients who stop taking anti-HIV drugs for short periods of time.

Conditions

HIV Infections

Keywords

Virus Replication; HIV-1; Drug Administration Schedule; AIDS Vaccines; RNA, Viral; Viral Load; HIV-1 immunogen, incomplete Freund's adjuvant; Treatment Interruption; HIV Therapeutic Vaccine

Interventions

HIV-1 Immunogen BIOLOGICAL

Structured Treatment Interruption PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be eligible for this study if they:
• Have been enrolled in A5057, which includes the 6-month extension.
• Have participated in A5057 for at least 44 weeks.
• Received at least 4 treatments on A5057.
• Are between 8 and 22 weeks from the last study injection on A5057.
• Have a viral load (amount of HIV in the blood) of 400 or less copies/ml at screening.
• Have a stable anti-HIV drug combination (no changes in anti-HIV drugs) for 8 or more weeks prior to entry.
• Have a CD4 count of 300 or more cells/ml at screening.
• Agree to use at least 1 approved method of birth control, if women able to have children. Birth control is not required if a male partner is infertile and provides evidence of that fact.
• Have a negative pregnancy test within 14 days of study entry.

You may not qualify if:

• Patients will not be eligible for this study if they:
• Are pregnant or breast-feeding.
• Are allergic to the study drugs.
• Have had an acute infection requiring an antibiotic, an outbreak of herpes simplex virus or herpes zoster, or other acute medical illness or surgery within 30 days prior to screening.
• Have received within 30 days of study entry GM-CSF, G-CSF, M-CSF, IFN, IL-2, or other cytokines; drugs affecting the immune system including cyclosporine, methotrexate, azathioprine, anti-CD25 antibody, or other agents; systemic oral or IV corticosteroids for 21 or more days; and HIV vaccine other than the one provided in this study; hydroxyurea; systemic cytotoxic chemotherapy; or medications that should not be taken with any HIV drugs being received.
• Have been assigned randomly to A5058s.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

MeSH Terms

Conditions

HIV Infections

Interventions

HIV-1 immunogen, incomplete Freund's adjuvant; Treatment Interruption

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Treatment Adherence and Compliance; Attitude to Health; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Fred Valentine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2001
• First Posted: August 31, 2001
• Last Updated: November 1, 2021

Record last verified: 2021-10