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| Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH) National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00068809 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Procedure: Short Cycle Antiretroviral Therapy |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | Short-Cycle Therapy in Adolescents Following Continuous Therapy With Established Viral Suppression: The Impact on Viral Load Suppression |
| Enrollment: | 31 |
| Study Start Date: | July 2003 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 12 Years to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects currently enrolled in ATN 015 Version 2.0 are eligible as follows:
Exclusion Criteria:
If a candidate fails the eligibility criteria (inclusion or exclusion), she or he may be screened again for eligibility after a period of 30 days.
Contacts and Locations| United States, California | |
| University of California at San Diego | |
| San Diego, California, United States, 92102 | |
| Children's Hopsital of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| 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 | |
| Puerto Rico | |
| 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 |
More Information
| Responsible Party: | Adolescent Trials Network ( Dr. Bret Rudy ) |
| Study ID Numbers: | ATN 015 v 3.0 |
| Study First Received: | September 10, 2003 |
| Last Updated: | February 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00068809 History of Changes |
| Health Authority: | United States: Federal Government |
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Treatment experienced Treatment interruption |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |