The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads.
A compilation of outcomes of various antiretroviral therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. Using data from present and recently completed studies, this study will collect information on therapies and their control of HIV infection and maintenance of durable suppression of HIV-1 replication. No treatment is provided by this study, but patients will continue to receive highly active antiretroviral therapy (HAART) from other studies in which they are coenrolled. Blood and urine collection will occur at study entry and periodically throughout the study. Women may undergo pelvic exams and Pap smears. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires will be completed periodically.
Study Type
OBSERVATIONAL
Enrollment
5,982
Successive suppressed viral load measures
Time frame: Measured 144 weeks after randomization
Genotypic or phenotypic resistance
Time frame: Measured at baseline and study completion
Complications of HIV disease, including survival, HIV-related opportunistic infections, HIV-related non-opportunistic complications, adverse effects of antiretroviral therapies of grade three or greater
Time frame: Measured throughout
Absolute number and percentage of CD4 and CD8 T cells
Time frame: Measured 144 weeks after randomization
Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells
Time frame: Measured 144 weeks after randomization
Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells
Time frame: Measured 144 weeks after randomization
Levels of immune activation markers, including CD8, CD38, and HLA-DR cells
Time frame: Measured 144 weeks after randomization
HIV-1 latency or replication in tissue or cellular reservoirs
Time frame: Measured at baseline, Week 16, Week 48, and study completion
Syncytium and non-syncytium inducing (SI/NSI) phenotype
Time frame: Measured at baseline, Week 16, Week 48, and study completion
Metabolic and neurologic complications
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Kaiser Permanente LAMC
Los Angeles, California, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
UCLA CARE Ctr
Los Angeles, California, United States
Willow Clinic
Menlo Park, California, United States
UC Davis Med Ctr
Sacramento, California, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, United States
Univ of California, San Francisco/San Francisco General Hosp
San Francisco, California, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States
Marin County Specialty Clinic
San Rafael, California, United States
...and 67 more locations
Time frame: Measured at baseline, Week 16, Week 48, and study completion
Immune responses to antigens such as cytomegalovirus (CMV), Myobacterium avium complex (MAC), Candida, and HIV
Time frame: Measured 144 weeks after randomization
Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs)
Time frame: Measured at baseline, Week 16, and study completion
Effect of gender, use of hormonal therapies, presence or absence of menopause on short- and long-term virologic suppression, and pap smear abnormalities
Time frame: Measured at baseline, Week 48, and study completion
Quality of life scores
Time frame: Measured at baseline, Week 48, and study completion
Subject-reported patterns of adherence
Time frame: Measured at baseline, Week 48, and study completion
Estimated inpatient, outpatient, and total costs
Time frame: Measured at study completion