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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000943
First received: November 2, 1999
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
HIV Infections
Biological: Tetanus Toxoid Vaccine
Biological: Hepatitis A Vaccine (Inactivated)
Biological: HIV-1 Immunogen
Biological: Hepatitis B Vaccine (Recombinant)

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Controlled, Pilot Study of the Immunogenicity of Remune in HIV-Infected Subjects Receiving Either Highly Active Antiretroviral Therapy (HAART) Alone or HAART and Interleukin-2 (IL-2): A Nested Substudy of ACTG 328

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 50
Study Completion Date: November 2005
Detailed Description:

Proliferative responses to HIV antigens are either absent or of small magnitude in HIV-infected patients, even in the early stages of infection when vigorous proliferative responses to recall antigens are still seen. Remune consists of an inactivated, gp120-depleted virus intended to stimulate HIV-specific immune responses. Remune has been reported to increase lymphocyte proliferative responses to HIV antigens in patients with high CD4 cell counts. Many other T-cell-dependent responses are also impaired in HIV-infected patients, such as after vaccination with hepatitis A or B vaccine. In this study, patients with moderately advanced HIV disease who have already received 52 weeks of either HAART or HAART plus IL-2 are vaccinated with Remune and a control recall immunogen, tetanus toxoid (TT), to evaluate whether these patients can develop new CD4 T-cell and CD8 T-cell responses to HIV-related antigens. The antibody response to hepatitis A and hepatitis B vaccinations also will be explored.

Fifty patients are enrolled in this substudy; 17 from the HAART only arm (Arm I of ACTG 328) and 33 from the HAART plus either CIV or subcutaneous IL-2 arms (Arms II and III of ACTG 328). All patients are vaccinated 3 times with Remune and twice with TT. If patients are hepatitis A total antibody negative, they receive hepatitis A vaccine twice. Additionally, if patients are hepatitis B surface antigen negative, hepatitis B core antibody and surface antibody negative, they receive hepatitis B vaccine 3 times. Patients who are negative for all hepatitis markers receive hepatitis A and B vaccines.

Week 0 of A5046s begins at or after Week 64 of ACTG 328 (for patients in the HAART-only arm) or 4 weeks after the initiation of the seventh or any subsequent IL-2 cycle of ACTG 328 (for patients in any of the IL-2-containing arms). [AS PER AMENDMENT 9/16/99: Patients can be screened through Week 124 of ACTG 328.] Patients receive Remune at Weeks 0, 8, and 16 and TT at Weeks 0 and 8. Hepatitis A and/or B vaccines are also given at these times, if indicated. Blood and skin tests are performed at Weeks 0, 8, 16, and 24 to measure immune response and lymphocyte proliferative responses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000943

Locations
United States, Iowa
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, United States, 52242
United States, New York
NY Univ. HIV/AIDS CRS
New York, New York, United States
Sponsors and Collaborators
Investigators
Study Chair: Hernan Valdez
Study Chair: Michael Lederman
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000943     History of Changes
Other Study ID Numbers: A5046s, ACTG 328 (Main Study), AACTG A5046s, 10794, ACTG A5046s
Study First Received: November 2, 1999
Last Updated: May 16, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Lymphocytes
Interleukin-2
Drug Therapy, Combination
AIDS Vaccines
CD4 Lymphocyte Count
Cell Division
HIV Core Protein p24
Anti-HIV Agents
HIV Therapeutic Vaccine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Interleukin-2
Analgesics
Analgesics, Non-Narcotic
Antineoplastic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014