- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00014937
Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brescia, Italy
- Spedali Civili - Carosi
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Genova, Italy
- Universita di Genova
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Milano, Italy
- Ospedale Luigi Sacco Milazzo
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Modena, Italy
- Università degli Studi di Modena e Reggio Emilia
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San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico
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California
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Los Angeles, California, United States, 900331079
- Univ of Southern California / LA County USC Med Ctr
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Colorado
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Denver, Colorado, United States, 80262
- Univ of Colorado Health Sciences Ctr
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Denver, Colorado, United States, 80262
- Denver Dept of Health and Hosps
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Connecticut
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Farmington, Connecticut, United States, 06030-3805
- Connecticut Children's Medical Center (Pediatric)
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Florida
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Miami, Florida, United States, 331361013
- Univ of Miami School of Medicine
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory Univ
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Hawaii
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Honolulu, Hawaii, United States, 96816
- Univ of Hawaii
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Honolulu, Hawaii, United States, 96816
- Queens Med Ctr
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Illinois
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Chicago, Illinois, United States, 60612
- The CORE Ctr
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Chicago, Illinois, United States, 60611
- Northwestern Univ Med School
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Chicago, Illinois, United States, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Indiana
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Indianapolis, Indiana, United States, 462025250
- Indiana Univ Hosp
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Indianapolis, Indiana, United States, 46202
- Methodist Hosp of Indiana / Life Care Clinic
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Indianapolis, Indiana, United States, 46202
- Wishard Hosp
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Charity Hosp / Tulane Univ Med School
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Univ of Minnesota
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Missouri
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Saint Louis, Missouri, United States, 63108
- Washington Univ / St Louis Connect Care
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St Louis, Missouri, United States, 63108
- Washington Univ School of Medicine
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Nebraska
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Omaha, Nebraska, United States, 681985130
- Univ of Nebraska Med Ctr
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New York
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Buffalo, New York, United States, 14215
- SUNY / Erie County Med Ctr at Buffalo
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New York, New York, United States, 10021
- Cornell Univ Med Ctr
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New York, New York, United States, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, United States, 10011
- Cornell Clinical Trials Unit - Chelsea Clinic
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Rochester, New York, United States, 14642
- Univ of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, United States, 275997215
- Univ of North Carolina
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Durham, North Carolina, United States, 27710
- Duke Univ Med Ctr
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Ohio
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Cincinnati, Ohio, United States, 452670405
- Univ of Cincinnati
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Cleveland, Ohio, United States, 44106
- Case Western Reserve Univ
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Cleveland, Ohio, United States, 441091998
- MetroHealth Med Ctr
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Columbus, Ohio, United States, 432101228
- Ohio State Univ Hosp Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Univ of Pennsylvania
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Washington
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Seattle, Washington, United States, 98104
- Univ of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- Viral resistance to study drugs as determined by resistance studies during ACTG 388
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Margaret Fischl, MD, University of Miami
Publications and helpful links
General Publications
- 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. doi: 10.1086/422518. Epub 2004 Jul 30.
- Tebas P, Zhang J, Yarasheski K, Evans S, Fischl MA, Shevitz A, Feinberg J, Collier AC, Shikuma C, Brizz B, Sattler F; AIDS Clinical Trials Group (ACTG). Switching to a protease inhibitor-containing, nucleoside-sparing regimen (lopinavir/ritonavir plus efavirenz) increases limb fat but raises serum lipid levels: results of a prospective randomized trial (AIDS clinical trial group 5125s). J Acquir Immune Defic Syndr. 2007 Jun 1;45(2):193-200. doi: 10.1097/QAI.0b013e318042e204.
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Ritonavir
- Lopinavir
- Lamivudine
- Zidovudine
- Stavudine
- Didanosine
- Efavirenz
- Lamivudine, zidovudine drug combination
Other Study ID Numbers
- A5116
- AACTG 5116
- Substudy AACTG A5124s
- Substudy AACTG A5125s
- ACTG A5116
- 10934 (Registry Identifier: DAIDS-ES)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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