A Study to Test If Giving Remune (an HIV Vaccine) Can Improve the Immune Systems of HIV-Positive Patients Who Are Also Participating in ACTG 328

NCT00000943 | Completed

• 5 other identifiers: A5046sACTG 328 (Main Study)AACTG A5046s10794ACTG A5046s
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the effects of an HIV vaccine (Remune) on the immune system. This study involves patients who have received at least 60 weeks of anti-HIV therapy, either alone or in combination with IL-2, while enrolled in ACTG 328. Remune is an experimental HIV vaccine. To see how the body's immune system reacts, this vaccine will be given with 1 to 3 other vaccines, and skin tests will monitor the body's reaction.

Conditions

HIV Infections

Keywords

Lymphocytes; Interleukin-2; Drug Therapy, Combination; AIDS Vaccines; CD4 Lymphocyte Count; Cell Division; HIV Core Protein p24; Anti-HIV Agents; HIV Therapeutic Vaccine

Interventions

Tetanus Toxoid Vaccine BIOLOGICAL

Hepatitis A Vaccine (Inactivated) BIOLOGICAL

HIV-1 Immunogen BIOLOGICAL

Hepatitis B Vaccine (Recombinant) BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• Patients may be eligible for this study if they:
• Have completed at least 60 weeks of treatment on ACTG 328.
• Are willing to continue on their assigned ACTG 328 treatment until after they have completed 24 weeks on this substudy.
• Have a viral load less than or equal to 2,000 copies/ml.

You may not qualify if:

• Patients will not be eligible for this study if they:
• Have an active opportunistic (HIV-related) infection.
• Are pregnant or breast-feeding.
• Have taken or are taking certain medications that are prohibited.

Sponsors & Collaborators

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

Study Sites (2)

Univ. of Iowa Healthcare, Div. of Infectious Diseases

Iowa City, Iowa, 52242, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, United States

Location

Related Publications (1)

• Valdez H, Mitsuyasu R, Landay A, Sevin AD, Chan ES, Spritzler J, Kalams SA, Pollard RB, Fahey J, Fox L, Namkung A, Estep S, Moss R, Sahner D, Lederman MM. Interleukin-2 Increases CD4+ lymphocyte numbers but does not enhance responses to immunization: results of A5046s. J Infect Dis. 2003 Jan 15;187(2):320-5. doi: 10.1086/346056. Epub 2003 Jan 6.

  PMID: 12552459 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Tetanus Toxoid; Hepatitis A Vaccines; HIV-1 immunogen, incomplete Freund's adjuvant; Hepatitis B Vaccines

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)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Viral Hepatitis Vaccines; Viral Vaccines

Study Officials

• Hernan Valdez

  STUDY CHAIR

• Michael Lederman

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: November 1, 2005
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (2)