Stopping and Restarting Anti-HIV Drugs in Children and Adolescents With Low Blood Levels of HIV
Intensification of HIV-Specific CD4 and CD8 Activity by Cycling Highly Active Antiretroviral Therapy (HAART) in Pediatric/Adolescent Patients With Less Than 50 HIV RNA Copies/ml
4 other identifiers
observational
39
2 countries
17
Brief Summary
Some patients taking anti-HIV drugs as part of highly active antiretroviral therapy (HAART) do not show any HIV in the blood; however, some HIV will remain hidden in the body and, if the drugs are stopped, will return to the blood. The purpose of this study is to determine if short periods of stopping HAART increase the activity of CD8 and CD4 cells (cells of the immune system that fight infection), if repeated stopping of these drugs for longer periods of time and restarting them will increase effectiveness of HAART, and if the increased immune system activity as a result of stopping treatment leads to lower levels of HIV over time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedOctober 7, 2013
October 1, 2013
June 2, 2001
October 4, 2013
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- HIV infected
- For Cohort 1, CD4 T-cell percent greater than 20
- For Cohort 2, CD4 T-cell percent greater than 25
- Viral load less than 400 copies/ml in the year prior to study entry and less than 50 copies/ml at screening
- Taking anti-HIV drugs (including at least 1 protease inhibitor) and have been on anti-HIV drugs for at least 1 year prior to study entry
- Have been on their current drug regimen for at least 4 months
- Willing to follow study procedures
- Parental or guardian consent if under 18 years old
- Acceptable forms of contraception
You may not qualify if:
- Taking abacavir, nevirapine, efavirenz, or delavirdine
- AIDS-related or other infections needing drug treatment at study entry
- Pregnant or breastfeeding
- Have, or have had in the past, diseases (other than HIV infection) or other conditions that, in the doctor's opinion, would interfere with the study
- Taking experimental drugs without the consent of the protocol team
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Children's Hosp of Denver
Denver, Colorado, 802181088, United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 21287, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714, United States
St. Lukes/Roosevelt Hosp Ctr
New York, New York, 10025, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
University of Rochester Medical Center
Rochester, New York, 14642-0001, United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030, United States
San Juan City Hosp
San Juan, 009367344, Puerto Rico
Related Publications (5)
Chun TW, Davey RT Jr, Engel D, Lane HC, Fauci AS. Re-emergence of HIV after stopping therapy. Nature. 1999 Oct 28;401(6756):874-5. doi: 10.1038/44755. No abstract available.
PMID: 10553903BACKGROUNDDavey RT Jr, Bhat N, Yoder C, Chun TW, Metcalf JA, Dewar R, Natarajan V, Lempicki RA, Adelsberger JW, Miller KD, Kovacs JA, Polis MA, Walker RE, Falloon J, Masur H, Gee D, Baseler M, Dimitrov DS, Fauci AS, Lane HC. HIV-1 and T cell dynamics after interruption of highly active antiretroviral therapy (HAART) in patients with a history of sustained viral suppression. Proc Natl Acad Sci U S A. 1999 Dec 21;96(26):15109-14. doi: 10.1073/pnas.96.26.15109.
PMID: 10611346BACKGROUNDGarcia F, Plana M, Vidal C, Cruceta A, O'Brien WA, Pantaleo G, Pumarola T, Gallart T, Miro JM, Gatell JM. Dynamics of viral load rebound and immunological changes after stopping effective antiretroviral therapy. AIDS. 1999 Jul 30;13(11):F79-86. doi: 10.1097/00002030-199907300-00002.
PMID: 10449278BACKGROUNDNeumann AU, Tubiana R, Calvez V, Robert C, Li TS, Agut H, Autran B, Katlama C. HIV-1 rebound during interruption of highly active antiretroviral therapy has no deleterious effect on reinitiated treatment. Comet Study Group. AIDS. 1999 Apr 16;13(6):677-83. doi: 10.1097/00002030-199904160-00008.
PMID: 10397562BACKGROUNDRuiz L, Martinez-Picado J, Romeu J, Paredes R, Zayat MK, Marfil S, Negredo E, Sirera G, Tural C, Clotet B. Structured treatment interruption in chronically HIV-1 infected patients after long-term viral suppression. AIDS. 2000 Mar 10;14(4):397-403. doi: 10.1097/00002030-200003100-00013.
PMID: 10770542BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
William Borkowsky, MD
New York University Medical Center, Pediatric Infectious Diseases