A Comparison of Two Anti-HIV Treatment Plans
A Randomized Study of a Prescribed 4-Month Structured Treatment Interruption (STI) Followed by Initiation of a New Antiretroviral Regimen Versus Immediate Initiation of a New Antiretroviral Regimen in HIV-Infected Patients With Multidrug Resistant (MDR) Virus
2 other identifiers
observational
480
1 country
21
Brief Summary
The purpose of this study is to compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients who are resistant to the drug effects. Sometimes the increase in a patient's viral load (the level of HIV in the blood) can be slowed or stopped by taking anti-HIV drugs. This does not always happen. Sometimes anti-HIV drugs work at first but then stop working. When most of the usual anti-HIV drugs no longer seem to work, the virus is called multidrug-resistant (MDR). This study will compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients with MDR virus.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
21 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedOctober 1, 2013
September 1, 2013
June 15, 2000
September 28, 2013
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Patients may be eligible if they:
- Have proof of MDR virus from a blood test.
- Have a viral load above 5,000 copies/ml from the same blood sample showing MDR virus.
- Intend to start a new anti-HIV treatment around the time of the study.
- Have been on a stable anti-HIV treatment between 14 days prior to the blood test mentioned above and when they are randomly assigned to a treatment.
- Are at least 13 years old (consent of parent or guardian required if under 18).
- (This protocol has been changed to reflect new criteria.)
You may not qualify if:
- Patients will not be eligible if they:
- Have received a vaccine or had an illness that might affect viral load within 14 days before the blood test showing MDR virus.
- Have received IL-2 within 4 months of the above-mentioned blood test or plan to take IL-2 during the study.
- Have an opportunistic (AIDS-related) infection requiring treatment.
- Are pregnant or breast-feeding.
- Are currently participating in CPCRA 057 (PIP study).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Community Consortium / UCSF
San Francisco, California, 94110, United States
Lawrence Goldyn, MD
San Francisco, California, 94110, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 80204, United States
Univ Hosp Infectious Disease
Denver, Colorado, 80204, United States
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
New Haven, Connecticut, 06510, United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112, United States
Our Lady of the Lake Regional Med Ctr
New Orleans, Louisiana, 70112, United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Southern New Jersey AIDS Clinical Trials
Camden, New Jersey, 08103, United States
North Jersey Community Research Initiative
Newark, New Jersey, 07103, United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York, New York, 10037, United States
Bronx-Lebanon Hosp Ctr
The Bronx, New York, 10453, United States
The Research and Education Group
Portland, Oregon, 97210, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Montrose Clinic
Houston, Texas, 77006, United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030, United States
Univ TX Health Science Ctr
Houston, Texas, 77030, United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, 23298, United States
Related Publications (4)
Lawrence J, Mayers DL, Hullsiek KH, Collins G, Abrams DI, Reisler RB, Crane LR, Schmetter BS, Dionne TJ, Saldanha JM, Jones MC, Baxter JD; 064 Study Team of the Terry Beirn Community Programs for Clinical Research on AIDS. Structured treatment interruption in patients with multidrug-resistant human immunodeficiency virus. N Engl J Med. 2003 Aug 28;349(9):837-46. doi: 10.1056/NEJMoa035103.
PMID: 12944569BACKGROUNDAnti-HIV agents. An attempt at treatment interruption--trial CPCRA 064. TreatmentUpdate. 2003 Aug-Sep;15(5):4-5. No abstract available.
PMID: 17216857RESULTLawrence J, Hullsiek KH, Thackeray LM, Abrams DI, Crane LR, Mayers DL, Jones MC, Saldanha JM, Schmetter BS, Baxter JD. Disadvantages of structured treatment interruption persist in patients with multidrug-resistant HIV-1: final results of the CPCRA 064 study. J Acquir Immune Defic Syndr. 2006 Oct 1;43(2):169-78. doi: 10.1097/01.qai.0000242450.74779.ee.
PMID: 16951642RESULTPaquet AC, Baxter J, Weidler J, Lie Y, Lawrence J, Kim R, Bates M, Coakley E, Chappey C. Differences in reversion of resistance mutations to wild-type under structured treatment interruption and related increase in replication capacity. PLoS One. 2011 Jan 31;6(1):e14638. doi: 10.1371/journal.pone.0014638.
PMID: 21297946RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jody Lawrence
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2000
First Posted
August 31, 2001
Study Completion
June 1, 2004
Last Updated
October 1, 2013
Record last verified: 2013-09