Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy (HAART) in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315

Summary

To evaluate the relationship between viral suppression and changes in immune function, as measured by the restoration of delayed-type hypersensitivity (DTH) and lymphoproliferative (LP) responses, observed after 48 weeks of treatment with highly active antiretroviral therapy (HAART) in ACTG 315. To evaluate the durability of the antiviral and immunologic effects of long-term treatment with HAART. Given the extensive immunologic and virologic data available from ACTG 315, follow-up studies of this advanced-disease population are indicated to primarily ascertain the impact of long-term suppression of viral replication on immunologic reconstitution or re-education and the durability of the antiviral effects of HAART.

Timeline

Start

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Primary completion

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Completion

2004-05

Publications

• Background Smith KY, Valdez H, Landay A, Spritzler J, Kessler HA, Connick E, Kuritzkes D, Gross B, Francis I, McCune JM, Lederman MM. Thymic size and lymphocyte restoration in patients with human immunodeficiency virus infection after 48 weeks of zidovudine, lamivudine, and ritonavir therapy. J Infect Dis. 2000 Jan;181(1):141-7. doi: 10.1086/315169.
• Background Valdez H, Connick E, Lederman M, Smith K, Fox L, St. T-lymphocyte changes after 3 years of controlled viral replication. Clair M, Bosch R, Kim R, Blanchard M, Landay A. 8th Conf Retro and Opportun Infect 2001 Feb 4-8 (abstract no 372)
• Background Valdez H, Smith KY, Landay A, Connick E, Kuritzkes DR, Kessler H, Fox L, Spritzler J, Roe J, Lederman MB, Lederman HM, Evans TG, Heath-Chiozzi M, Lederman MM. Response to immunization with recall and neoantigens after prolonged administration of an HIV-1 protease inhibitor-containing regimen. ACTG 375 team. AIDS Clinical Trials Group. AIDS. 2000 Jan 7;14(1):11-21. doi: 10.1097/00002030-200001070-00002.
• Background Valdez H, Smith K, Lederman M, Landay A, Kessler H, Connick E, Kuritzkes D, Spritzler J, Fox L, Roe J, Lederman H, Lederman MB, Evans T. Response to immunization with recall and neoantigens after 48 weeks of HAART. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:130 (abstract no 329)
• Background Smith KY, Valdez H, Landay A, Connick E, Gross B, Wade M, Lederman M. Correlations between immunologic indices and thymic mass in HIV infected patients following 48 weeks of therapy with zidovudine, lamivudine and ritonavir (ZLR). Int Conf AIDS. 1998;12:264 (abstract no 21129)
• Background Wu H, Connick E, Kuritzkes DR, Landay A, Spritzler J, Zhang B, Spear GT, Kessler H, Lederman MM; ACTG 315 Team. Multiple CD4+ cell kinetic patterns and their relationships with baseline factors and virological responses in HIV type 1 patients receiving highly active antiretroviral therapy. AIDS Res Hum Retroviruses. 2001 Sep 1;17(13):1231-40. doi: 10.1089/088922201750461285.

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