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
6 other identifiers
interventional
240
3 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedJuly 29, 2013
July 1, 2013
April 14, 2001
July 26, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
- Acceptable methods of contraception
- Consent of parent or legal guardian if under 18 years of age
You may not qualify if:
- Viral resistance to study drugs as determined by resistance studies during ACTG 388
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
Denver Dept of Health and Hosps
Denver, Colorado, 80262, United States
Univ of Colorado Health Sciences Ctr
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 / St Louis Connect Care
St Louis, Missouri, 63108, United States
Washington Univ School of Medicine
St Louis, Missouri, 63108, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130, 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
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
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, 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
Ospedale Luigi Sacco Milazzo
Milan, Italy
Universita degli Studi di Modena e Reggio Emilia
Modena, Italy
Univ of Puerto Rico
San Juan, 009365067, Puerto Rico
Related Publications (2)
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.
PMID: 15356820BACKGROUNDTebas 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.
PMID: 17527093RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Margaret Fischl, MD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2001
First Posted
August 31, 2001
Primary Completion
December 1, 2004
Last Updated
July 29, 2013
Record last verified: 2013-07