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.
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, proof of concept trial 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. Eligible participants who have been on standard HAART therapy consisting of a Protease Inhibitor will switch to SCT therapy(4 days on treatment, 3 days off treatment each week) at entry. Participants will be seen in the clinic every other Monday during the first month, then monthly up to 24-weeks and then once every two months until the end of the 48-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 until week 24 and every 4-weeks thereafter until week 48. Fasting serum triglycerides and cholesterol will be measured at baseline, at week 24 and at the end of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Children's Hopsital of Los Angeles
Los Angeles, California, United States
University of California at San Diego
San Diego, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Assess VL Suppression for Subjects on SCT over a 24 Week and 48 Week Period
To assess viral load suppression (≤ 400 copies/ml) for subjects on SCT over a 24 week and a 48 week period. The primary endpoint is defined as the time of confirmed VL \> 400 copies/ml at any time after study entry up to and including the 48th week of follow-up.
Time frame: 48 Weeks
Assess CD4+ T-cell count over time for subjects on SCT from baseline to week 48
To assess CD4+ T-cell count over time for subjects on SCT from baseline to week 48. These values will be compared at (1) the period of time from study entry to viral load rebound (\> 400 copies/ml), (2) the period of time from study entry to subject dropout, or (3) the period of time from study entry to administrative end of study at 48 weeks, depending on each subject's disposition.
Time frame: 48 Weeks
Compare differences in various values from study entry to Weeks 24 and 48
To compare differences in fasting cholesterol, triglycerides, LDL, HDL, and VLDL levels from study entry to weeks 24 and 48
Time frame: 48 Weeks
Assess the adherence level over time
To assess the adherence level over time using the PACTG Pediatric Adherence Questionnaire Module I, every two weeks up to week 24 and every four weeks until week 48
Time frame: Week 48
Assess genotypic resistance as necessary
To assess subject-specific plasma genotypic resistance for subjects with viral load \>1000 copies/ml at time of viral load rebound.
Time frame: 48 Weeks
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Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States
University of Miami
Miami, Florida, United States
Stoger Hospital of Cook County
Chicago, Illinois, United States
Mt. Sinai Hospital
New York, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Puerto Rico
San Juan, Puerto Rico