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Home > "A" Clinical Trials Conditions > A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation  A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation
A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - 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 Exclusion Criteria - 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
Total Enrollment: 375
Location and Contact Information:
Overall Study Official:
DonnaMildvan, Study Chair, Beth Israel Medical Center
Rhode Island Hospital *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Univ of Rochester Med Ctr *Recruiting*
Rochester, New York, 14215
United States
Recruiting Carol Greisberger 585-275-2740
Univ of Maryland, Institute of Human Virology *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Susan LaSalvia 410-706-2785
Bellevue Hosp / New York Univ Med Ctr *Recruiting*
New York City, New York, 10016
United States
Recruiting Maura Laverty 212-263-6565
Indiana Univ Hosp *Recruiting*
Indianapolis, Indiana, 46202-5250
United States
Recruiting Beth Zwickl 317-274-8456
Johns Hopkins Univ *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Charles Raines 410-614-4487
Univ of Pennsylvania, Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Joseph Quinn 215-349-8092
Beth Israel Deaconess - West Campus *No longer recruiting*
Boston, Massachusetts, 02215
United States
No longer recruiting
Beth Israel Med Ctr *Recruiting*
New York City, New York, 10003
United States
Recruiting Ann Marshak 212-420-4432
Univ of Puerto Rico *Recruiting*
San Juan, , 00936-5067
Puerto Rico
Recruiting Raquel Colon-Otero 787-767-9192
Univ of North Carolina *Recruiting*
Chapel Hill, North Carolina, 27514
United States
Recruiting Cheryl Marcus 919-843-8761
Miriam Hosp/Brown Univ *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Stanley Street Treatment and Resource *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Univ of Washington *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
Methodist Hosp of Indiana *Recruiting*
Indianapolis, Indiana, 46202-1261
United States
Recruiting Sarah Ryan 317-929-2917
The Moses H. Cone Memorial Hosp *Recruiting*
Greensboro, North Carolina, 27401-1004
United States
Recruiting Lisa Dasnoit 336-832-8062
Univ of Miami *Recruiting*
Miami, Florida, 33136
United States
Recruiting Leslie Thompson 305-243-3838
Univ of Colorado Health Sciences Ctr *Recruiting*
Denver, Colorado, 80262
United States
Recruiting M. Ray 303-372-5535
University of Hawaii *Recruiting*
Honolulu, Hawaii, 96816-2396
United States
Recruiting Debra Ogata-Arakaki 808-737-2751
University of Witwatersrand *Recruiting*
Parktown/Gauteng, Johnnesburg,
South Africa
Recruiting Pauline Vunandlala 01-27-11-717-2810
MetroHealth Med Ctr *Recruiting*
Cleveland, Ohio, 44109-1998
United States
Recruiting Ann Conrad 216-778-5489
Ohio State University *Recruiting*
Columbus, Ohio,
United States
Recruiting Todd Lusch 614-293-8112
Wishard Hosp *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Scott Hamilton 317-630-6023
Univ of California, Davis Med Ctr *Recruiting*
Sacramento, California, 95814
United States
Recruiting Susan Hulse 916-734-8637
Community Health Network, Inc *Recruiting*
Rochester, New York, 14642-0001
United States
Recruiting Carol Greisberger 585-275-2740
Additional Information:
Study ID Numbers: ACTG A5073; AACTG A5073
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036452
Other Hiv Infections Studies:
1. A Phase I Safety and Immunogenicity Study of HIV p17/p24:Ty-VLP in HIV-1 Seronegative Subjects
2. A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease
3. A Pilot Open Label Trial of HIV Therapy with d4T (Stavudine), ddI (Didanosine), Nelfinavir and Hydroxyurea in Subjects with Early Asymptomatic HIV Infection
4. Underlying abnormalities in fat and muscle leading to Lipodystrophy Syndrome
5. A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy
Related Studies:
Other HIV Infections Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation
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