Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen
- Conditions
- HIV Infections
- Registration Number
- NCT00014937
- Brief Summary
ACTG 388 was a clinical trial that compared three- and four-drug anti-HIV drug regimens and demonstrated the effectiveness of a three-drug regimen. This study will compare the ability of two different three-drug anti-HIV drug regimens to reduce levels of HIV in the blood. The study will also evaluate whether patients discontinue the regimens because of drug side effects.
- Detailed Description
ACTG 388 was designed to evaluate two four-drug regimens compared with a three-drug regimen in patients who were relatively treatment naive. Based on the increased complexity and toxicity of four-drug regimens and the resultant negative impact on response as compared with three-drug regimens, studies evaluating simplified potent regimens appear warranted. This study will evaluate simpilified drug regimens designed to enhance virologic activity without necessarily increasing the number of antiretroviral drugs. The study regimens will be assessed for both virologic control and tolerability. The study population will include patients previously enrolled in ACTG 388 and patients with prior advanced HIV disease who received and responded to potent antiretroviral therapy without evidence of virologic relapse.
Patients will be stratified according to ACTG 388 treatment or non-ACTG 388 study participation. Patients will then be randomized to receive either a protease inhibitor (PI)-sparing regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) with efavirenz (EFV) (Arm I) or an NRTI-sparing regimen of EFV with lopinavir/ritonavir (LPV/r) (Arm II). Arm I options are enteric-coated didanosine (ddI-EC) plus lamivudine (3TC), ddI-EC plus zidovudine (ZDV), ZDV plus 3TC (or Combivir), stavudine (d4T) plus 3TC, or ddI-EC plus d4T (with exceptions as noted in the protocol). Only LPV/r, EFV, d4T, and ddI are provided by the study; other medications are obtained by nonstudy prescription.
All patients are evaluated for safety and for virologic and immunologic responses at Weeks 4 and 8, then every 8 weeks until the study ends. In addition, all patients have assessments for fat redistribution, fasting lipid profiles, fasting insulin levels, venous lactate levels, and treatment adherence. Patients will be followed for 1.5 to 3 years. Interim safety analyses will be conducted in June 2002 and June 2003. Patients in this study may also enroll in A5125s, a fat distribution and bone mineral density substudy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Spedali Civili - Carosi
🇮🇹Brescia, Italy
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Emory Univ
🇺🇸Atlanta, Georgia, United States
Wishard Hosp
🇺🇸Indianapolis, Indiana, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
Methodist Hosp of Indiana / Life Care Clinic
🇺🇸Indianapolis, Indiana, United States
Cornell Clinical Trials Unit - Chelsea Clinic
🇺🇸New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
The CORE Ctr
🇺🇸Chicago, Illinois, United States
Ospedale Luigi Sacco Milazzo
🇮🇹Milano, Italy
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Charity Hosp / Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
MetroHealth Med Ctr
🇺🇸Cleveland, Ohio, United States
Universita di Genova
🇮🇹Genova, Italy
Queens Med Ctr
🇺🇸Honolulu, Hawaii, United States
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States
Connecticut Children's Medical Center (Pediatric)
🇺🇸Farmington, Connecticut, United States
Washington Univ / St Louis Connect Care
🇺🇸Saint Louis, Missouri, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Univ of Nebraska Med Ctr
🇺🇸Omaha, Nebraska, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Washington Univ School of Medicine
🇺🇸St Louis, Missouri, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Universita degli Studi di Modena e Reggio Emilia
🇮🇹Modena, Italy
Univ of Puerto Rico
🇵🇷San Juan, Puerto Rico
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Denver Dept of Health and Hosps
🇺🇸Denver, Colorado, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Univ of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States