Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen - Article Sustiva
Clinical Trial: Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen
This study has been completed.
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.
|Condition||Treatment or Intervention|
|HIV Infections || Drug: lopinavir/ritonavir |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study
Official Title: A Randomized, Controlled Trial of Two Potent, Simplified Regimens Utilizing A Protease Inhibitor-Sparing Regimen Versus A Nucleoside-Sparing Regimen for HIV-Infected Subjects Who Participated in ACTG 388 or Who Responded to A First Potent Combination Regimen and Have 200 or Less HIV-1 RNA Copies/ml
Expected Total Enrollment: 240
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.
Ages Eligible for Study: 13 Years and above, Genders Eligible for Study: Both
Inclusion Criteria for ACTG 388 Participants
- HIV-1 RNA level <= 200 copies/ml within 70 days of study entry
- Stable anti-HIV drug plan without harmful drug side effects or serious illness at the time of study entry
Inclusion Criteria for Non-ACTG 388 Participants
- Potent anti-HIV drug regimen as a first HIV treatment for at least 18 months
- HIV-1 RNA level >= 80,000 copies/ml or CD4+ count <= 200 cells/mm3 prior to starting anti-HIV drug regimen
- HIV-1 RNA level <= 400 copies/ml (or less than 500 copies/ml by bDNA) within 32 weeks of initial therapy
- HIV-1 RNA level <= 200 copies/ml within 60 days of study entry
Inclusion Criteria for Both ACTG 388 and Non-ACTG 388 Participants
- Acceptable methods of contraception
- Consent of parent or legal guardian if under 18 years of age
Exclusion Criteria for ACTG 388 Participants
Exclusion Criteria for ACTG 388 and Non-ACTG 388 Participants
- Pregnancy or breastfeeding
- Certain heart medicines (flecainide or propafenone); antihistamines (astemizole and terfenadine); rifampin; ergot derivatives (dihydroergotamine, ergonovine, ergotamine, or methylergonovine); intestinal agents (cisapride); herbal products (St. John's wort); lovastatin or simvastatin; neuroleptics (pimozide); and sedatives/hypnotics (midazolam or triazolam)
- Allergy study drugs
Univ of Southern California / LA County USC Med Ctr, Los Angeles, California, 900331079, United States
Univ of Colorado Health Sciences Ctr, Denver, Colorado, 80262, United States
Denver Dept of Health and Hosps, Denver, Colorado, 80262, United States
Connecticut Children's Medical Center (Pediatric), Farmington, Connecticut, 06030-3805, United States
Univ of Miami School of Medicine, Miami, Florida, 331361013, United States
Emory Univ, Atlanta, Georgia, 30308, United States
Queens Med Ctr, Honolulu, Hawaii, 96816, United States
Univ of Hawaii, Honolulu, Hawaii, 96816, United States
Northwestern Univ Med School, Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois, 60612, United States
The CORE Ctr, Chicago, Illinois, 60612, United States
Indiana Univ Hosp, Indianapolis, Indiana, 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic, Indianapolis, Indiana, 46202, United States
Wishard Hosp, Indianapolis, Indiana, 46202, United States
Charity Hosp / Tulane Univ Med School, New Orleans, Louisiana, 70112, United States
Univ of Minnesota, Minneapolis, Minnesota, 55455, United States
Washington Univ School of Medicine, St. Louis, Missouri, 63108, United States
Washington Univ / St Louis Connect Care, Saint Louis, Missouri, 63108, United States
Univ of Nebraska Med Ctr, Omaha, Nebraska, 681985130, United States
Univ of Rochester Medical Center, Rochester, New York, 14642, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York, 10016, United States
Cornell Univ Med Ctr, New York, New York, 10021, United States
SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York, 14215, United States
Cornell Clinical Trials Unit - Chelsea Clinic, New York, New York, 10011, United States
Univ of North Carolina, Chapel Hill, North Carolina, 275997215, United States
Duke Univ Med Ctr, Durham, North Carolina, 27710, United States
Case Western Reserve Univ, Cleveland, Ohio, 44106, United States
Univ of Cincinnati, Cincinnati, Ohio, 452670405, United States
Ohio State Univ Hosp Clinic, Columbus, Ohio, 432101228, United States
MetroHealth Med Ctr, Cleveland, Ohio, 441091998, United States
Univ of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
Univ of Washington, Seattle, Washington, 98104, United States
Spedali Civili - Carosi, Brescia, Italy
Universita di Genova, Genova, Italy
Universita degli Studi di Modena e Reggio Emilia, Modena, Italy
Ospedale Luigi Sacco Milazzo, Milano, Italy
Univ of Puerto Rico, San Juan, 009365067, Puerto Rico
Margaret Fischl, MD, Study Chair, University of Miami
Click here for more information about zidovudine.
Click here for more information about didanosine.
Click here for more information about stavudine.
Click here for more information about lamivudine.
Click here for more information about efavirenz.
Click here for more information about lamivudine/zidovudine.
Click here for more information about lopinavir/ritonavir.
Haga clic aquí para ver información sobre este ensayo clínico en español.
Demeter LM, Ribaudo HJ, Erice A, Eshleman SH, Hammer SM, Hellmann NS, Fischl MA; AIDS Clinical Trials Group Protocol 388. HIV-1 drug resistance in subjects with advanced HIV-1 infection in whom antiretroviral combination therapy is failing: a substudy of AIDS Clinical Trials Group Protocol 388. Clin Infect Dis. 2004 Aug 15;39(4):552-8. Epub 2004 Jul 30.
Record last reviewed: February 2005
Last Updated: April 7, 2005
Record first received: April 14, 2001
ClinicalTrials.gov Identifier: NCT00014937
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005