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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tetanus Toxoid Vaccine
Hepatitis A Vaccine (Inactivated)
HIV-1 Immunogen
Hepatitis B Vaccine (Recombinant)
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Lymphocytes, Interleukin-2, Drug Therapy, Combination, AIDS Vaccines, CD4 Lymphocyte Count, Cell Division, HIV Core Protein p24, Anti-HIV Agents, HIV Therapeutic Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ. of Iowa Healthcare, Div. of Infectious Diseases
  • NY Univ. HIV/AIDS CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000943
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Tetanus Toxoid Vaccine
Intervention Type
Biological
Intervention Name(s)
Hepatitis A Vaccine (Inactivated)
Intervention Type
Biological
Intervention Name(s)
HIV-1 Immunogen
Intervention Type
Biological
Intervention Name(s)
Hepatitis B Vaccine (Recombinant)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hernan Valdez
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Lederman
Official's Role
Study Chair
Facility Information:
Facility Name
Univ. of Iowa Healthcare, Div. of Infectious Diseases
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12552459
Citation
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.
Results Reference
background

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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

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