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 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 time until treatment-limiting toxicity OR occurrence of Grades 3 or 4 toxicity
Trial Locations
- Locations (60)
Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States
USC CRS
🇺🇸Los Angeles, California, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Univ. of California Davis Med. Ctr., ACTU
🇺🇸Sacramento, California, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
Santa Clara Valley Med. Ctr.
🇺🇸San Jose, California, United States
San Mateo County AIDS Program
🇺🇸San Mateo, California, United States
Scroll for more (50 remaining)Alabama Therapeutics CRS🇺🇸Birmingham, Alabama, United States