This study will determine if taking anti-HIV drugs 4 days a week will control HIV-1 viral replication in patients who have already had at least 6 months of documented viral suppression with full-time treatment. If this strategy is shown to be safe in this study, a larger study will be undertaken to determine if the strategy can decrease overall drug exposure and help young people adjust more easily to a chronic medication schedule.

Condition	Treatment or Intervention	Phase
HIV Infections	Procedure: Short Cycle Antiretroviral Therapy	Phase II

HIV infected adolescents who require therapy face a lifetime of antiretroviral treatment. Highly active antiretroviral therapy (HAART) is associated with short- and long-term complications, and concerns are mounting about the cumulative effect of these complications as adolescents enter the third and fourth decade of life. A management strategy that can suppress the virus and decrease overall drug exposure is needed. In addition, the scheduling requirements for antiretroviral therapies interfere with the socialization and independence that an adolescent must accomplish to gain skills for a successful adult life. Not surprisingly, nonadherence to prescribed medications is common in teens. This multicenter, prospective, randomized Phase II study will evaluate Short Cycle Therapy (SCT) in adolescents with sustained viral suppression of at least 6 months. While maintenance of viral load suppression can be viewed as either a safety or efficacy endpoint, the trial is constructed as an assessment of safety.

Participants will be randomized to one of two groups: SCT (4 days on treatment, 3 days off treatment each week) or continuous (standard) therapy. Participants will be seen in the clinic every other Monday during the first month, then monthly until the end of the 24-week study period. Plasma HIV RNA levels and CD4 cell counts will be performed at every visit. Medication adherence by self-report will be conducted every 2 weeks. Fasting serum triglycerides and cholesterol will be measured at baseline and at study end.

Ages Eligible for Study:  12 Years   -   24 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• HIV infected after the age of 9 years
• HAART regimen with documented viral control for at least 6 months prior to study entry
• HAART regimen containing a protease inhibitor (PI) and no nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 3 months prior to study entry
• Willing to remain on PI-containing regimen throughout the study duration
• At least three plasma HIV-1 RNA levels =< 400 copies/ml within the past 12 months and no plasma HIV-1 RNA levels > 400 copies/ml within 6 months of pre-entry date
• Pre-screening plasma HIV-1 RNA level < 50 copies/ml within 30 days of study entry
• CD4 cell count > 350 cells/microL within 30 days prior to study entry
• Ability of subject and parent/legal guardian to give assent/consent/permission
• Acceptable methods of contraception

Exclusion Criteria

• HAART regimen containing an NNRTI or abacavir
• Certain medications
• Active HIV-related opportunistic infection or any malignancy at the time of screening
• Current treatment for known or suspected active serious bacterial infection
• Pregnancy
• Any laboratory abnormalities Grade 3 or greater as defined by protocol toxicity table

Sushma Dangol, MBBS MPH      301-294-3842    sushmadangol@westat.com

California
      University of California at San Diego, San Diego,  California,  United States; Recruiting
      Children's Hopsital of Los Angeles, Los Angeles,  California,  United States; Recruiting
District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010,  United States; Recruiting
Florida
      Children's Diagnostic and Treatment Center, Fort Lauderdale,  Florida,  United States; Recruiting
      University of Miami, Miami,  Florida,  United States; Recruiting
      University of Miami, Miami,  Florida,  United States
Illinois
      Stoger Hospital of Cook County, Chicago,  Illinois,  United States; Recruiting
New York
      Mt. Sinai Hospital, New York City,  New York,  United States; Recruiting
Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  United States; Recruiting
Puerto Rico
      University of Puerto Rico, San Juan,  Puerto Rico; Recruiting

Study chairs or principal investigators

Bret J Rudy, MD,  Study Chair,  Children's Hospital of Philadelphia, The University of Pennsylvania School of Medicine   

Study ID Numbers:  ATN 015
Record last reviewed:  November 2003
Record first received:  September 10, 2003
ClinicalTrials.gov Identifier:  NCT00068809
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-22