Status:

COMPLETED

A Study to Evaluate the Effects of Giving IL-2 Alone to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3 Who Do Not Wish to Receive Anti-HIV Therapy

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of giving interleukin-2 (IL-2) alone to HIV-positive patients with CD4 cell counts greater than 350 cells/mm3 who do not wish to re...

Detailed Description

Previous studies have shown that interleukin-2, when given under the skin, results in CD4+ cell count increases, and may impact upon disease progression. A Phase III trial is the next step in the deve...

Eligibility Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have had at least one CD4 cell count greater than or equal to 350 cells/mm3 within 30 days of study entry.
  • Are at least 18 years old.
  • Agree to abstinence or use of effective methods of birth control 1 month before and during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have a history of a potentially life-threatening autoimmune or inflammatory disease.
  • Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect their safety or ability to complete the study.
  • Have a history of an AIDS-defining illness.
  • Have a history of cancer, other than Kaposi's sarcoma.
  • Have ever taken IL-2 or any antiretroviral medications.
  • Are pregnant.
  • Are taking certain medications, including anti-seizure medications.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

June 1 2004

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT00000909

End Date

June 1 2004

Last Update

October 29 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Kobler Ctr. of Chelsea Westminster Hosp. C604-030 CRS

London, United Kingdom