Status:

COMPLETED

Treatment With Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This study examines the long-term effects of interleukin-2 (IL-2) in combination with anti-HIV drugs, or highly active antiretroviral therapy (HAART). The purpose of this study is to see if IL-2 can i...

Detailed Description

HIV disease is characterized by a progressive decline in CD4 cells and an increase in viral burden. Although antiretroviral therapy has been successful in controlling viral levels, its effects on CD4 ...

Eligibility Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have completed at least 84 weeks of treatment on ACTG 328.
  • Have had a 25 percent or greater increase in CD4 cell count above the ACTG 328 Week 11 value (only applies to patients who received IL-2 during ACTG 328).
  • Are 18 years of age or older.
  • Agree to practice abstinence or use a barrier method of birth control (such as condoms) during the study. (This study has been changed. Hormonal methods of birth control such as birth control pills are no longer allowed.)

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have significant heart disease or are taking certain heart medications. Patients with hypertension who are being treated are eligible.
  • Have taken certain medications that might affect the immune system within 4 weeks of study entry including corticosteroids, interferons, or thalidomide.
  • Have taken rifampin, rifabutin, or St. John's wort within 7 days of study entry. (This study has been changed. St. John's wort was not in the original version.)
  • Are taking certain investigational anti-HIV drugs.
  • Are taking indinavir and any of the following within 2 weeks of study entry: cisapride, terfenadine, astemizole, midazolam, triazolam, ketoconazole, itraconazole, or delavirdine.
  • Have cancer requiring chemotherapy. Local radiation therapy is allowed.
  • Have untreated thyroid disease.
  • Are allergic to albumin.
  • Have a serious mental illness.
  • Have a history of an autoimmune disease, including inflammatory bowel disease and psoriasis.
  • Have a central nervous system disease or seizures, if these have been active within 1 year prior to study entry.
  • Abuse drugs or alcohol.
  • Are pregnant or breast-feeding.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

August 1 2004

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT00000923

End Date

August 1 2004

Last Update

May 21 2012

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Alabama Therapeutics CRS

Birmingham, Alabama, United States, 35294

2

USC CRS

Los Angeles, California, United States, 900331079

3

Harbor-UCLA Med. Ctr. CRS

Torrance, California, United States, 90502

4

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, United States, 96816