Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Reverse Transcriptase Inhibitors, HIV Protease Inhibitors, Drug Therapy, Combination, Delayed Action Preparations, Treatment Naive, HIV-1
Eligibility Criteria
Inclusion Criteria for Step 1: HIV infected HIV viral load of 2000 copies/ml or greater within 60 days prior to study entry Willing to use acceptable means of contraception d4T XR, TDF, or ZDV chosen as part of an initial regimen prior to randomization to a study arm Coenrolled in ACTG A5152s Exclusion Criteria for Step 1: On ARV therapy for 7 days or more any time prior to study entry NNRTIs or 3TC at any time prior to study entry Current peripheral neuropathy of Grade 2 or higher Pregnancy or breastfeeding Immunomodulators, vaccines, or investigational therapies within 30 days of study entry. Patients taking a stable or tapering dose of prednisone at less than 10 mg are not excluded. Human growth hormone within 30 days prior to study entry Initiation of testosterone or anabolic steroids within 30 days prior to study entry Certain other medications within 30 days of study entry Hypersensitivity to components of the study drug formulations Drug or alcohol use or dependence that would interfere with adherence to study requirements Acute therapy for serious medical illnesses requiring systemic treatment and/or hospitalization within 14 days prior to study entry Recent infection with drug-resistant HIV
Sites / Locations
- Alabama Therapeutics CRS
- USC CRS
- UCLA CARE Center CRS
- Stanford CRS
- UC Davis Medical Center
- Univ. of California Davis Med. Ctr., ACTU
- Ucsd, Avrc Crs
- Ucsf Aids Crs
- Santa Clara Valley Med. Ctr.
- San Mateo County AIDS Program
- Harbor-UCLA Med. Ctr. CRS
- University of Colorado Hospital CRS
- Georgetown University CRS (GU CRS)
- Univ. of Miami AIDS CRS
- The Ponce de Leon Ctr. CRS
- Univ. of Hawaii at Manoa, Leahi Hosp.
- Northwestern University CRS
- Rush Univ. Med. Ctr. ACTG CRS
- Cook County Hosp. CORE Ctr.
- Methodist Hosp. of Indiana
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
- Indiana Univ. School of Medicine, Wishard Memorial
- Univ. of Iowa Healthcare, Div. of Infectious Diseases
- IHV Baltimore Treatment CRS
- Johns Hopkins Adult AIDS CRS
- Massachusetts General Hospital ACTG CRS
- Bmc Actg Crs
- Beth Israel Deaconess Med. Ctr., ACTG CRS
- Brigham and Women's Hosp. ACTG CRS
- SSTAR, Family Healthcare Ctr.
- University of Minnesota, ACTU
- St. Louis ConnectCare, Infectious Diseases Clinic
- Washington U CRS
- Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
- SUNY - Buffalo, Erie County Medical Ctr.
- Beth Israel Med. Ctr., ACTU
- NY Univ. HIV/AIDS CRS
- Cornell CRS
- Columbia Univ., HIV Prevention and Treatment Medical Ctr.
- HIV Prevention & Treatment CRS
- Weill Med. College of Cornell Univ., The Cornell CTU
- Univ. of Rochester ACTG CRS
- AIDS Care CRS
- McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit
- Unc Aids Crs
- Duke Univ. Med. Ctr. Adult CRS
- Wake County Health and Human Services CRS
- Univ. of Cincinnati CRS
- Case CRS
- MetroHealth CRS
- Cleveland Clinic Foundation, Div. of Medicine, Infectious Diseases
- The Ohio State Univ. AIDS CRS
- Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
- Hosp. of the Univ. of Pennsylvania CRS
- Pitt CRS
- Rhode Island Hosp.
- The Miriam Hosp. ACTG CRS
- Vanderbilt Therapeutics CRS
- University of Washington AIDS CRS
- Durban Adult HIV CRS