Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00050895
- Brief Summary
With new strategies and drugs available, many different regimens exist for the treatment of HIV. The purpose of this study is to compare three different anti-HIV drug regimens as first-time treatments for HIV infection.
- Detailed Description
Numerous treatment options are available to HIV infected patients who are antiretroviral (ARV) therapy naive, but an optimal regimen has not yet been established. This study will compare a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen, a ritonavir (RTV)-enhanced protease inhibitor (PI)-based regimen, and a nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimen for the initial treatment of HIV infection.
Patients will be randomly assigned to one of three study arms. In Arm A, patients will receive lopinavir/ritonavir (LPV/r) twice daily and efavirenz (EFV) once daily before bed. Arm B patients will receive LPV/r twice daily, lamivudine (3TC) once daily, plus either stavudine extended release (d4T XR) once daily, zidovudine (ZDV) twice daily, or tenofovir disoproxil fumarate (TDF) once daily. Patients in Arm C will receive EFV once daily before bed and 3TC plus either d4T XR once daily before bed, ZDV twice daily, or TDF once daily before bed.
Study visits will occur every 4 weeks until Week 24, then every 8 weeks thereafter for a maximum of 96 weeks. Blood will be drawn at every visit and a urine sample will be collected every 8 weeks. Body measurements will be taken at Weeks 24, 48, 72, and 96. Whole body dual-energy x-ray absorptiometry (DEXA) scans will be done at Weeks 48 and 96. Patients must fast before study visits at Weeks 12, 24, 48, 72, and 96. Women in the study will have gynecological assessments every 24 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 775
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time from study entry to virologic failure time from study entry to regimen completion
- Secondary Outcome Measures
Name Time Method 20 % or more increase in truncal fat accumulation change from baseline of whole-body bone density and whole-body bone mineral content at Weeks 48 and 96 change from baseline in self-reported symptoms OR occurrence of reporting an increase in symptoms at Weeks 4, 48, 72 and 96 increase in lactic acid levels at least 2-4old above the upper limit of normal (ULN) fasting cholesterol level equal to or greater than 240 mg/dl change from baseline in insulin resistance at Weeks 24, 48 and 96 number of antiretroviral classes with resistance mutations at virologic failure number of missed medication doses 4 days prior time until treatment-limiting toxicity OR occurrence of Grades 3 or 4 toxicity 20 % or more loss in peripheral fat Grade 3 or greater elevation in fasting triglyceride levels change from baseline in body image OR occurrence of reporting body image distress at Weeks 24, 48, 72 and 96 time to confirmed virologic failure while on Steps I (initial randomized regimen) or II (within class substitutes for initial regimen toxicity) OR treatment-limiting toxicity on Steps I or II
Trial Locations
- Locations (60)
IHV Baltimore Treatment CRS
🇺🇸Baltimore, Maryland, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
The Ponce de Leon Ctr. CRS
🇺🇸Atlanta, Georgia, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
Case CRS
🇺🇸Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital ACTG CRS
🇺🇸Boston, Massachusetts, United States
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
Brigham and Women's Hosp. ACTG CRS
🇺🇸Boston, Massachusetts, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
Pitt CRS
🇺🇸Pittsburgh, Pennsylvania, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Indiana Univ. School of Medicine, Wishard Memorial
🇺🇸Indianapolis, Indiana, United States
Bmc Actg Crs
🇺🇸Boston, Massachusetts, United States
Durban Adult HIV CRS
🇿🇦Durban, KwaZulu-Natal, South Africa
USC CRS
🇺🇸Los Angeles, California, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
San Mateo County AIDS Program
🇺🇸San Mateo, California, United States
Santa Clara Valley Med. Ctr.
🇺🇸San Jose, California, United States
Harbor-UCLA Med. Ctr. CRS
🇺🇸Torrance, California, United States
Georgetown University CRS (GU CRS)
🇺🇸Washington, District of Columbia, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Univ. of Iowa Healthcare, Div. of Infectious Diseases
🇺🇸Iowa City, Iowa, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
🇺🇸Boston, Massachusetts, United States
SSTAR, Family Healthcare Ctr.
🇺🇸Fall River, Massachusetts, United States
St. Louis ConnectCare, Infectious Diseases Clinic
🇺🇸Saint Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
Cornell CRS
🇺🇸New York, New York, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
Beth Israel Med. Ctr., ACTU
🇺🇸New York, New York, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
Columbia Univ., HIV Prevention and Treatment Medical Ctr.
🇺🇸New York, New York, United States
HIV Prevention & Treatment CRS
🇺🇸New York, New York, United States
AIDS Care CRS
🇺🇸Rochester, New York, United States
Weill Med. College of Cornell Univ., The Cornell CTU
🇺🇸New York, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit
🇺🇸Rochester, New York, United States
Wake County Health and Human Services CRS
🇺🇸Raleigh, North Carolina, United States
MetroHealth CRS
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation, Div. of Medicine, Infectious Diseases
🇺🇸Cleveland, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
🇺🇸Philadelphia, Pennsylvania, United States
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
🇺🇸Philadelphia, Pennsylvania, United States
Rhode Island Hosp.
🇺🇸Providence, Rhode Island, United States
The Miriam Hosp. ACTG CRS
🇺🇸Providence, Rhode Island, United States
Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Univ. of California Davis Med. Ctr., ACTU
🇺🇸Sacramento, California, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
🇺🇸Omaha, Nebraska, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS
🇺🇸Durham, North Carolina, United States
Vanderbilt Therapeutics CRS
🇺🇸Nashville, Tennessee, United States