A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation

Completed · Phase 2

Conditions studied: HIV Infections

In brief

Anti-HIV drug therapy works best when the drugs are taken exactly as prescribed by a doctor. Because anti-HIV therapy often involves multiple drugs, some people have difficulty taking them all correctly. The easier it is to take anti-HIV drugs, the more likely people will take them as prescribed and get the best results. This study will see if people are more successful in taking anti-HIV drugs once a day or twice a day. It also will determine if having a health care professional oversee each weekday dose helps people control their HIV infection. The study will compare taking a three-drug combination twice a day versus taking a three-drug combination just once a day. The study will also compare patients taking the drugs on their own to patients taking the drugs in the presence of a clinical worker. Viral load (amount of HIV in the blood) and drug side effects will be measured.

Key facts

Study ID

NCT00036452

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

402

Expected to finish

2006-01-01

Last updated by the study team

2021-11-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV infection
• Age 13 years or older and have written consent of guardian if under 18
• Weigh at least 88 pounds
• Viral load of 2000 copies/ml or more within 90 days before study entry
• Have not taken anti-HIV drugs for more than 7 days
• Agree to use acceptable methods of contraception during the study and for 1 month after stopping the study drugs

You may not qualify if…

• Pregnant or breastfeeding
• In jail
• Sensitive or allergic to any part of the study drugs
• Treated with acute systemic therapy for a serious infection or other serious medical illness within 7 days prior to study entry, unless the participant has completed 7 days of therapy and is clinically stable
• Recent serious illness, including pancreatitis or peripheral neuropathy
• Alcohol or illicit drug abuse
• Taken any of the following within 14 days before study entry: investigational drugs, anti-HIV vaccines, drugs that may cause pancreatitis or peripheral neuropathy, or drugs that are associated with CYP3A
• Treated for cancer (not including minimal Kaposi's sarcoma) within 30 days before study entry
• History of mental illness that might interfere with the study

Where it is running

• USC CRS — Los Angeles, California, United States
• Univ. of California Davis Med. Ctr., ACTU — Sacramento, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• IHV Baltimore Treatment CRS — Baltimore, Maryland, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• SSTAR, Family Healthcare Ctr. — Fall River, Massachusetts, United States
• University of Minnesota, ACTU — Minneapolis, Minnesota, United States
• Beth Israel Med. Ctr., ACTU — New York, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• AIDS Care CRS — Rochester, New York, United States
• McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit — Rochester, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• Regional Center for Infectious Disease, Wendover Medical Center CRS — Greensboro, North Carolina, United States
• Wake County Health and Human Services CRS — Raleigh, North Carolina, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• MetroHealth CRS — Cleveland, Ohio, United States
• The Ohio State Univ. AIDS CRS — Columbus, Ohio, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States
• Pitt CRS — Pittsburgh, Pennsylvania, United States
• The Miriam Hosp. ACTG CRS — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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