4-Day-A-Week Treatment Plan for HIV Infected Adolescents
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Short-Cycle Therapy in Adolescents Following Continuous Therapy With Established Viral Suppression: The Impact on Viral Load Suppression|
- Assess VL Suppression for Subjects on SCT over a 24 Week and 48 Week Period [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
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.
- Assess CD4+ T-cell count over time for subjects on SCT from baseline to week 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]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.
- Compare differences in various values from study entry to Weeks 24 and 48 [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]To compare differences in fasting cholesterol, triglycerides, LDL, HDL, and VLDL levels from study entry to weeks 24 and 48
- Assess the adherence level over time [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]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
- Assess genotypic resistance as necessary [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]To assess subject-specific plasma genotypic resistance for subjects with viral load >1000 copies/ml at time of viral load rebound.
|Study Start Date:||July 2003|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Experimental: Short-cycle therapy (SCT)
At entry, subjects will switch from continuous HAART to SCT. All subjects will then be followed to assess viral load breakthrough over 48 weeks on SCT.
|Procedure: Short Cycle Antiretroviral Therapy|
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.
|United States, California|
|Children's Hopsital of Los Angeles|
|Los Angeles, California, United States, 90027|
|University of California at San Diego|
|San Diego, California, United States, 92102|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|United States, Florida|
|Children's Diagnostic and Treatment Center|
|Fort Lauderdale, Florida, United States, 33316|
|University of Miami|
|Miami, Florida, United States, 33101|
|United States, Illinois|
|Stoger Hospital of Cook County|
|Chicago, Illinois, United States, 60612|
|United States, New York|
|Mt. Sinai Hospital|
|New York City, New York, United States, 01129|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Puerto Rico|
|San Juan, Puerto Rico, 00927|
|Study Chair:||Bret J Rudy, MD||Children's Hospital of Philadelphia, The University of Pennsylvania School of Medicine|