Immune and Viral Status of HIV-Infected Patients After Stopping Combination Antiretroviral Therapy

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

Keywords

ClinConnect Summary

Highly active antiretroviral therapy (HAART) has been successful in controlling HIV levels in infected patients, but it is not effective in eliminating the virus from the patient and life-long therapy is thought to be required. However, proper adherence to HAART regimens is costly, results in inconveniences to patients, and is not without significant acute and long-term risks. Many patients are interested in undergoing treatment interruption to relieve these inconveniences and risks. This study seeks to identify these patients and to monitor them for virologic and immunologic parameters dur...

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Subjects greater than or equal to 18 years of age.
• • HIV infection confirmed by ELISA and Western blot.
• • Ability to sign informed consent and willingness to comply with study requirements and clinic policies.
• • In the judgment of the PI, patient has satisfactory knowledge of the benefits of continuing HAART as well as the risks of discontinuing such treatment. The patient has a private physician and the decision to interrupt antiretroviral therapy, the target point (i.e. viral load or CD4+ T cell count) to reinitiate therapy, and the regiment of antiretrovirals used upon re-initiation of therapy will be made with this private physician.
• • History of at least 2 months of ongoing HAART, defined as a minimum three drug regimen consisting of at least two nucleoside analogs and one protease inhibitor or two nucleoside analogs and one NNRTI or three nucleosides in place of other drug classes OR patients that are currently off therapy who are planning on resuming or initiating a HAART regimen within the next 3 months.
• • No baseline CD4 counts greater than or equal to 350 cells/microL, with confirmation, within the last 3 months.
• • Asymptomatic for significant HIV-related illnesses, such as opportunistic infections and malignancies other than mucocutaneous Kaposi's sarcoma.
• • For patients on IL-2 therapy, agreement to resume HAART while undergoing treatment cycles.
• EXCLUSION CRITERIA:
• • Psychiatric illness that, in the opinion of the PI, might interfere with study compliance.
• • Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety.
• • Women who are pregnant or breastfeeding.
• • Creatinine greater than 2.
• • Liver function tests greater than 5 times the normal laboratory values.
• • Platelet count less than 100,000/mm(3), hemoglobin less than 9 mg/dL, neutrophils less than 750/mm(3).
• • PT or PTT (in the absence of documented anti-cardiolipin antibody) prolonged by greater than 2 seconds.
• • Known underlying bleeding disorder.
• • Significant cardiac, pulmonary, kidney, rheumatologic, gastrointestinal, or CNS disease as detectable on routine history, physical examination, or screening laboratory studies.
• • History of significant opportunistic infection or HIV-associated malignancy.
• • Patient must not ever have had a total CD4 count of less than or equal to 150 cells/cubic millimeter during the year prior to enrollment. At least 2 measurements, possibly including the measurement during the screening visit and/or H\&P visit, must be available.
• • Due to a possible increased risk of a hypersensitivity reaction, patients on an abacavir-containing regimen will not be eligible for treatment interruption.
• • Patients with chronic hepatitis B infection receiving treatment with 3TC (lamivudine), adefovir, or tenofovir for suppresion are not eligible for this study.

Trial Officials