Completed

Phase Not Applicable
Age: 18Years +
All Genders
ID00000943

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29

50

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official 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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 2 locations

1

Univ. of Iowa Healthcare, Div. of Infectious Diseases

Iowa City, Iowa, United States, 52242

Status Unknown

2

NY Univ. HIV/AIDS CRS

New York, New York, United States

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Interleukin-2 Increases CD4+ lymphocyte numbers but does not enhance responses to immunization: results of A5046s.

Hernan Valdez, Ronald Mitsuyasu, Alan Landay...

https://pubmed.ncbi.nlm.nih.gov/12552459