Use of Combination Antiviral Therapy to Delineate the Identity and Longevity of Persistent Reservoirs of HIV-1 Infection and Replication

Date de début de l'étude : 3 mars 1997

INCLUSION CRITERIA: Greater than or equal to 18 years old. Ability to sign informed consent and willingness to comply with study requirements and clinic policies. For women of child-bearing potential, negative result on pregnancy test within one week prior to initiating therapy. No medical contraindication to lymph node biopsy. HIV infection confirmed by ELISA and Western blot. Two CD4+ T cell counts less than 300/microliters within 3 months of beginning the protocol, with one of the two counts obtained at a screening history and physical examination performed 2 weeks prior to initiating therapy. Plasma HIV-1 RNA levels greater than 8000/ml. For participants with CD4 T cell counts greater than or equal to 300/microliter, asymptomatic for significant HIV-related illnesses. For participants with CD4 T cell counts less than or equal to 300/microliter no active opportunistic infections. For participants with greater than or equal to 300 CD4 cells/ microliter, no prior receipt of antiretroviral therapy. For participants with less than or equal to 300 CD4 cells/microliter, no prior use of lamivudine, nevirapine or protease inhibitors. Three or more palpable lymph nodes. Willingness to allow storage of samples for future research. Willingness to allow HLA testing. EXCLUSION CRITERIA: Platelet count less than 100,000 platelets/mm(3). PT or PTT (in the absence of documented anti-cardiolipin antibody) prolonged by greater than 2 seconds. Known underlying bleeding disorder. Pregnancy or breastfeeding. Psychiatric illness that might interfere with study compliance. Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety. Creatinine greater than 2. Liver function tests greater than 1.5 times the normal laboratory values. Significant cardiac, pulmonary, kidney, rheumatologic, gastrointestinal, or CNS disease as detectable on routine history, physical examination, or screening laboratory studies.