Clinical Trials


Stopping and Restarting Anti-HIV Drugs in Children and Adolescents With Low Blood Levels of HIV

This study has been completed
National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: June 2, 2001
Last updated: October 4, 2013
Last Verified: October 2013
History of Changes


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.

HIV Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 39
Study Completion Date: October 2006

Detailed Description:

Some HIV infected patients taking HAART have been able to achieve prolonged suppression of HIV viral load for extended periods of time. However, discontinuing HAART has consistently resulted in HIV's return to plasma. Both CD8 and CD4 cells are markedly reduced in individuals with prolonged HIV suppression; control of and response to cell-associated HIV is dependent on immune-mediated mechanisms involving these cells. It is hypothesized that a brief and low-level increase in HIV levels resulting from HAART interruption might boost HIV-specific CD8 and CD4 T-cell counts. After suppression of viral load with the reintroduction of HAART, the expanded CD8 population might be able to better control viral replication and better respond to cell-associated HIV. Future treatment interruption may lead to longer periods of undetectable viral loads.
Patients are divided into 2 age cohorts, with Cohort 1 consisting of children and adolescents 4 years and older up to 21 years of age, and Cohort 2 consisting of children and adolescents 2 years and older up to 4 years of age. Patients will be assigned to one of 2 groups. Group A patients will participate in drug holiday cycles from HAART and then back to HAART; Group B is a control group that remains on continuous HAART throughout the study. Cycle 1 for Group A patients begins with 18 days of HAART and a 3-day drug holiday. At the end of the drug holiday, viral load is measured and HAART is resumed for 28 days (detectable virus cycle) if viral load is detectable after the drug holiday. If viral load remains below the level of detection, the patient begins the next drug holiday cycle. With each subsequent drug holiday cycle, time off HAART will increase by 2 days. Patients failing 4 repeated detectable virus (28-day treatment) cycles will be taken off study.
Patients will be enrolled in this study for a minimum of 142 weeks. For Group A, HIV viral load and CD4 cell count are measured at the end of each drug holiday and each HAART resumption; HIV-specific CD4 and CD8 responses are measured every 3 cycles; and cell-associated HIV is assessed at entry, at 12-week intervals, and at the end of the study. For Group B, physical exams are conducted and HIV viral load and other blood work are measured every 12 weeks.



Ages Eligible for Study: 2 Years to 21 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


Note: A Study Monitoring Committee (SMC) recommended on 06/22/05 that this study close, because the primary objectives in this proof-of-concept study could not be achieved. As of 06/28/05, Group A participants will discontinue their drug holiday cycles and will be given the best possible therapy. All participants in this study will have a final study visit to be scheduled as soon as possible, prior to 07/29/05.
Inclusion Criteria:

  • 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

Exclusion Criteria:
  • 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00016783


United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
United States, Colorado
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
United States, District of Columbia
Howard Univ Hosp
Washington, District of Columbia, United States, 20060
United States, Florida
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
United States, Illinois
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
United States, Maryland
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
United States, New Jersey
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
United States, New York
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10457
St. Lukes/Roosevelt Hosp Ctr
New York, New York, United States, 10025
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Harlem Hosp Ctr
New York, New York, United States, 10037
University of Rochester Medical Center
Rochester, New York, United States, 14642-0001
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
United States, Texas
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030
Puerto Rico
San Juan City Hosp
San Juan, Puerto Rico, 009367344

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)


Study Chair: William Borkowsky, MD New York University Medical Center, Pediatric Infectious Diseases
More Information

More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00016783   History of Changes  
Other Study ID Numbers: P1015  
  PACTG P1015  
  ACTG P1015  
Study First Received: June 2, 2001  
Last Updated: October 4, 2013  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Drug Therapy, Combination
Drug Administration Schedule
HIV Protease Inhibitors
CD4 Lymphocyte Count
CD8-Positive T-Lymphocytes
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Antiretroviral Therapy, Highly Active
Treatment Experienced
Treatment Interruption

Additional relevant MeSH terms:
HIV Infections
Anti-Retroviral Agents processed this data on March 27, 2020
This information is provided by