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

Keywords

ClinConnect Summary

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

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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.

Trial Officials