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4-Day-A-Week Treatment Plan for HIV Infected Adolescents Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about 4-Day-A-Week Treatment Plan for HIV Infected Adolescents conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 4-Day-A-Week Treatment Plan for HIV Infected Adolescents Clinical research trials and 4-Day-A-Week Treatment Plan for HIV Infected Adolescents healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as 4-Day-A-Week Treatment Plan for HIV Infected Adolescents. 4-Day-A-Week Treatment Plan for HIV Infected Adolescents Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a 4-Day-A-Week Treatment Plan for HIV Infected Adolescents clinical trial. Subjects frequently obtain the most expert healthcare possible for their 4-Day-A-Week Treatment Plan for HIV Infected Adolescents condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "4" Clinical Trials Conditions > 4-Day-A-Week Treatment Plan for HIV Infected Adolescents  4-Day-A-Week Treatment Plan for HIV Infected Adolescents
4-Day-A-Week Treatment Plan for HIV Infected Adolescents
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): 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)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety Study
Minimum Age/Maximum Age: 12 Years/24 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 160
Location and Contact Information:
Overall Study Official:
BretRudy, Study Chair, Children's Hospital of Philadelphia, The University of Pennsylvania School of Medicine
University of Puerto Rico *Recruiting*
San Juan, ,
Puerto Rico
Recruiting Evelyn Rivera 787-759-9595
University of Miami
Miami, Florida,
United States
Donna Maturo 305-243-3442
Children's Diagnostic and Treatment Center *Recruiting*
Ft. Lauderdale, Florida,
United States
Recruiting Esmine Leonard 954-728-1125
University of California at San Diego *Recruiting*
San Diego, California,
United States
Recruiting Lisa Stangl 619-543-8080
University of Miami *Recruiting*
Miami, Florida,
United States
Recruiting Donna Maturo 305-243-3442
Stoger Hospital of Cook County *Recruiting*
Chicago, Illinois,
United States
Recruiting Kelly Bojan 312-572-4571
Mt. Sinai Hospital *Recruiting*
New York City, New York,
United States
Recruiting Mary Geiger 212-423-2867
Children's Hopsital of Los Angeles *Recruiting*
Los Angeles, California,
United States
Recruiting Diane Tucker 323-660-2450
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania,
United States
Recruiting Mary Tanney 215-590-4954
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010
United States
Recruiting Connie Trexler 202-884-3714
Additional Information:
Study ID Numbers: ATN 015;
Study Start Date: July 2003
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068809
Other Hiv Infections Studies:
1. Heterosexual HIV Transmission Study (HATS)
2. A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)
3. A Pilot Study of the Patterns of Cellular Gene Expression in HIV-1 Patients Following Clinical Events Which Increase Plasma Virus Concentrations
4. A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B)
5. Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant
Related Studies:
Other HIV Infections Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
4-Day-A-Week Treatment Plan for HIV Infected Adolescents
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