Directly Observed Therapy for HIV Infected Adolescents

Completed · Not applicable

Conditions studied: HIV Infections

In brief

Adherence to a doctor-prescribed anti-HIV drug regimen is crucial in the management of HIV infection. In previous studies with tuberculosis patients, directly observed therapy (DOT), a strategy in which patients are observed while taking their medications, has been proven useful in increasing patient adherence. The purpose of this study is to determine the effectiveness of a new DOT strategy in HIV infected adolescents who have had difficulty adhering to anti-HIV drug regimens or regimens to prevent opportunistic infections (OIs) in the past.

Key facts

Study ID

NCT00259389

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

24

Starts

2006-04-01

Expected to finish

2007-09-01

Last updated by the study team

2012-09-18

Who can join

Age: 16 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infected with HIV after age 12
• Initiating, continuing, changing, or reinitiating a daily or twice-daily HAART regimen AND have demonstrated adherence problems (less than 85% of prescribed doses taken, as clinically disclosed, on 2 consecutive occasions at least 1 month apart). More information on this criterion can be found in the protocol.
• Able and willing to swallow medication
• Have access to HAART
• Parent or guardian willing to provide informed consent, if applicable
• Willing to use acceptable forms of contraception

You may not qualify if…

• Clinically significant diseases other than HIV infection or clinically significant findings during screening or physical examination that, in the opinion of the investigator, would require much closer follow-up and frequent monitoring than would be generally done for other HIV infected patients of comparable age
• HAART regimens that include medications taken more often than twice-daily
• Investigational agents (HAART or other medications) administered as part of other clinical trials
• Pregnant or breastfeeding

Where it is running

• Childrens Hospital Los Angeles — Los Angeles, California, United States
• Los Angeles County Medical Center/USC — Los Angeles, California, United States
• UCSD Mother, Child & Adolescent HIV Program — San Diego, California, United States
• Childrens Hospital of Michigan — Detroit, Michigan, United States
• University of Rochester Medical Center — Rochester, New York, United States
• St. Jude Childrens Research Hospital, Memphis — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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