Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
480 participants
OBSERVATIONAL
2004-06-30
Brief Summary
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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.
Detailed Description
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Patients are screened for the presence of MDR virus and a plasma HIV RNA level greater than 10,000 \[AS PER AMENDMENT 07/03/01: greater than 5,000\] copies/ml. Eligible patients attend a baseline visit \[AS PER AMENDMENT 07/03/01: and a subsequent randomization visit\] where the qualifying GART results are provided. Patients who consent to participate have phenotypic antiretroviral resistance testing (PART) done on a specimen from the same blood draw that was used for the GART evaluation. After PART results are available, patients are randomized \[AS PER AMENDMENT 07/03/01: If the predicted sensitivities are not available for some or all drugs included in the PART, the patient may still be randomized.\] to either a 4-month STI followed by a new antiretroviral regimen or an immediate new antiretroviral regimen. The antiretroviral regimens chosen are based on the patients' history and both GART and PART results. \[AS PER AMENDMENT 07/03/01: Additional GART and PART may be requested after at least 4 months of antiretroviral treatment.\] Patients have the follow-up data collection done at Months 1-8 and every 4 months thereafter. Changes in antiretroviral therapy, Grade 4 adverse experiences, progression of disease, and deaths are reported as they occur. Patients are seen for clinical management as often as deemed necessary. All patients are followed to a common closing date estimated to be 24 months after the last patient is randomized. Some patients may participate in a Point Mutation Substudy \[AS PER AMENDMENT 07/03/01: Plasma Point Mutation Substudy and PBMC Point Mutation Substudy\].
Conditions
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Keywords
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Eligibility Criteria
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Inclusion Criteria
* 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.)
Exclusion Criteria
* 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).
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Jody Lawrence
Role: STUDY_CHAIR
Locations
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Community Consortium / UCSF
San Francisco, California, United States
Lawrence Goldyn, MD
San Francisco, California, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States
Univ Hosp Infectious Disease
Denver, Colorado, United States
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
New Haven, Connecticut, United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States
Our Lady of the Lake Regional Med Ctr
New Orleans, Louisiana, United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, United States
Henry Ford Hosp
Detroit, Michigan, United States
Southern New Jersey AIDS Clinical Trials
Camden, New Jersey, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York, New York, United States
Bronx-Lebanon Hosp Ctr
The Bronx, New York, United States
The Research and Education Group
Portland, Oregon, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Montrose Clinic
Houston, Texas, United States
Houston Veterans Administration Med Ctr
Houston, Texas, United States
Univ TX Health Science Ctr
Houston, Texas, United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, United States
Countries
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References
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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.
Anti-HIV agents. An attempt at treatment interruption--trial CPCRA 064. TreatmentUpdate. 2003 Aug-Sep;15(5):4-5. No abstract available.
Lawrence 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.
Paquet 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.
Other Identifiers
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11619
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 064
Identifier Type: -
Identifier Source: org_study_id