Clinical Trials
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
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000943
First received: November 2, 1999
Last updated: May 16, 2012
Last Verified: May 2012
History of Changes
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 |
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
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 | |
Sexes Eligible for Study: | All | |
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.
- Have an active opportunistic (HIV-related) infection.
- Are pregnant or breast-feeding.
- Have taken or are taking certain medications that are prohibited.
Exclusion Criteria
Patients will not be eligible for this study if they:
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 Show More
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
National Institute of Allergy and Infectious Diseases (NIAID)Investigators
Study Chair: | Hernan Valdez | |
Study Chair: | Michael Lederman |
More Information
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 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
LymphocytesInterleukin-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:
HIV Infections
Vaccines
Interleukin-2
ClinicalTrials.gov processed this data on February 15, 2019
This information is provided by ClinicalTrials.gov.