Completed

Phase Not Applicable
All Genders
ID00001131

Procedure for Initiation, Administration, and Discontinuation of Interleukin-2 (IL-2) Therapy in Conjunction With Highly Active Antiretroviral Therapy

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2015-05-15

42

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to find out if the immune systems of HIV-positive patients can be improved by treatment with anti-HIV medications plus interleukin-2 (IL-2) in the early stages of HIV infection. IL-2 is a protein found naturally in the blood that can help boost the immune system. HIV spreads throughout the body by invading CD4 cells, which are cells of the immune system that fight infection. Doctors hope that adding IL-2 to a current anti-HIV drug combination can help restore the CD4 cell count and the immune functions. This study will look at how the HIV virus acts during the early stages of HIV infection, how the immune system responds to HIV, and what impact early treatment with anti-HIV medications has on the course of HIV infection.

CONDITIONS

Official Title

Effectiveness of Interleukin-2 (IL-2) Plus Anti-HIV Therapy in HIV-Positive Patients

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion Criteria

Patients may be eligible for this study if they:

  • HIV-infected.
  • Viral load of 5,000 copies/ml or less within 3 months.
  • Completed at least 3 months of anti-HIV medications.
  • Have a refrigerator to store the needles for IL-2 shots.

Exclusion Criteria

  • Glucocorticoids or other drugs that affect the immune system such as INF-alpha, G-CSF, or GM-CSF.
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: 1 location

1

Johns Hopkins Hosp

Baltimore, Maryland, United States, 21205

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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