A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation
- Conditions
- HIV Infections
- Registration Number
- NCT00036452
- Brief Summary
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.
- Detailed Description
While many factors contribute to the success or failure of antiretroviral therapy for HIV, among the most important are factors that influence adherence to a treatment regimen, such as duration of therapy, dosing frequency, pill burden, side effects, and patient behaviors. Inconsistent adherence or nonadherence to antiretroviral therapy can result in suboptimal drug exposure. Suboptimal drug exposure can, in turn, impact short- and long-term patient outcomes by increasing the likelihood of drug resistant HIV mutants and subsequent virologic and clinical failure. It is therefore essential to design treatment regimens that promote long-term adherence to potent antiretroviral therapy. This study will evaluate the relative contribution of reduced-frequency dosing and directly observed therapy on the magnitude and durability of virologic suppression in patients treated with potent antiretroviral therapy.
Patients will be randomly assigned to one of three study arms. Arms A, B, and C receive the same daily dosage of lopinavir/ritonavir (LPV/r), emtricitabine (FTC), and stavudine extended release (d4T XR) or tenofovir DF (TDF). In Arm A, drugs are self-administered for 48 weeks; LPV/r is taken twice daily and FTC and d4T XR or TDF once daily. In Arm B, all drugs are self-administered once daily for 48 weeks. In Arm C, drugs are taken once a day under directly observed therapy during Weeks 0-24, and then by self-administration during Weeks 25-48. Adherence to the regimen is measured using an electronic drug monitoring system. Viral load, CD4 and CD8 T cell responses, population pharmacokinetics, and quality of life indicators are measured throughout the study. The tolerability and safety of the treatment regimens are also monitored.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 402
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States
MetroHealth CRS
🇺🇸Cleveland, Ohio, United States
Pitt CRS
🇺🇸Pittsburgh, Pennsylvania, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Hosp. of the Univ. of Pennsylvania CRS
🇺🇸Philadelphia, Pennsylvania, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
USC CRS
🇺🇸Los Angeles, California, United States
Univ. of California Davis Med. Ctr., ACTU
🇺🇸Sacramento, California, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
IHV Baltimore Treatment CRS
🇺🇸Baltimore, Maryland, United States
SSTAR, Family Healthcare Ctr.
🇺🇸Fall River, Massachusetts, United States
Beth Israel Med. Ctr., ACTU
🇺🇸New York, New York, United States
McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit
🇺🇸Rochester, New York, United States
AIDS Care CRS
🇺🇸Rochester, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
Regional Center for Infectious Disease, Wendover Medical Center CRS
🇺🇸Greensboro, North Carolina, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
Wake County Health and Human Services CRS
🇺🇸Raleigh, North Carolina, United States
Wits HIV CRS
🇿🇦Johannesburg, Gauteng, South Africa
Vanderbilt Therapeutics CRS
🇺🇸Nashville, Tennessee, United States
Puerto Rico-AIDS CRS
🇵🇷San Juan, Puerto Rico
The Miriam Hosp. ACTG CRS
🇺🇸Providence, Rhode Island, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States