Search / Trial NCT00000923

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Interleukin 2 Drug Therapy, Combination Cd4 Lymphocyte Count Anti Hiv Agents Viral Load

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 cell counts have been modest. Intermittently administered IL-2 in the presence of HAART has been shown to increase CD4 cell counts, decrease lymphocyte activation markers, and increase certain lymphocyte functional activity in patients with early-stage HIV infection. ACTG 328 evaluated the effects of intravenous and/or subcutaneously administered IL-2 in conjunction with HAART in a group of mor...

Gender

All

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.

Attachments

readout_NCT00000923_2024-05-23.pdf

4.5 MB

NCT00000923_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Birmingham, Alabama, United States

Los Angeles, California, United States

Torrance, California, United States

Honolulu, Hawaii, United States

Iowa City, Iowa, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Seattle, Washington, United States

St. Louis, Missouri, United States

New York, New York, United States

New Orleans, Louisiana, United States

St Louis, Missouri, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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