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NCT00036452 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
A Randomized, Phase II, Open Label Study to Compare Twice Daily and Once Daily Potent Antiretroviral Therapy and to Compare Self-Administered Therapy and Therapy Administered Under Direct Observation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00036452
Other study ID # A5073
Secondary ID 10073ACTG A5073A
Status Completed
Phase Phase 2
First received
Last updated
Est. completion date January 2006

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 402
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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 during the study and for 1 month after stopping the study drugs 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• lopinavir/ritonavir

• emtricitabine

• stavudine

• tenofovir DF

Locations
Country Name City State
Puerto Rico Puerto Rico-AIDS CRS San Juan
South Africa Wits HIV CRS Johannesburg Gauteng
United States University of Colorado Hospital CRS Aurora Colorado
United States IHV Baltimore Treatment CRS Baltimore Maryland
United States Johns Hopkins Adult AIDS CRS Baltimore Maryland
United States Unc Aids Crs Chapel Hill 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 SSTAR, Family Healthcare Ctr. Fall River Massachusetts
United States Regional Center for Infectious Disease, Wendover Medical Center CRS Greensboro North Carolina
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 USC CRS Los Angeles California
United States Univ. of Miami AIDS CRS Miami Florida
United States University of Minnesota, ACTU Minneapolis Minnesota
United States Vanderbilt Therapeutics CRS Nashville Tennessee
United States Beth Israel Med. Ctr., ACTU New York New York
United States NY Univ. HIV/AIDS CRS New York New York
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 Wake County Health and Human Services CRS Raleigh North Carolina
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 Univ. of Rochester ACTG CRS Rochester New York
United States Univ. of California Davis Med. Ctr., ACTU Sacramento California
United States Ucsd, Avrc Crs San Diego California
United States University of Washington AIDS CRS Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico,  South Africa, 

References & Publications (7)

Bangsberg DR, Mundy LM, Tulsky JP. Expanding directly observed therapy: tuberculosis to human immunodeficiency virus. Am J Med. 2001 Jun 1;110(8):664-6. — View Citation

Flexner C, Tierney C, Gross R, Andrade A, Lalama C, Eshleman SH, Aberg J, Sanne I, Parsons T, Kashuba A, Rosenkranz SL, Kmack A, Ferguson E, Dehlinger M, Mildvan D; ACTG A5073 Study Team. Comparison of once-daily versus twice-daily combination antiretrovi — View Citation

Gross R, Tierney C, Andrade A, Lalama C, Rosenkranz S, Eshleman SH, Flanigan T, Santana J, Salomon N, Reisler R, Wiggins I, Hogg E, Flexner C, Mildvan D; AIDS Clinical Trials Group A5073 Study Team. Modified directly observed antiretroviral therapy compar — View Citation

Kirkland LR, Fischl MA, Tashima KT, Paar D, Gensler T, Graham NM, Gao H, Rosenzweig JR, McClernon DR, Pittman G, Hessenthaler SM, Hernandez JE; NZTA4007 Study Team. Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatment. Clin Infect Dis. 2002 Feb 15;34(4):511-8. Epub 2002 Jan 4. — View Citation

Liu H, Golin CE, Miller LG, Hays RD, Beck CK, Sanandaji S, Christian J, Maldonado T, Duran D, Kaplan AH, Wenger NS. A comparison study of multiple measures of adherence to HIV protease inhibitors. Ann Intern Med. 2001 May 15;134(10):968-77. Erratum in: Ann Intern Med 2002 Jan 15;136(2):175. — View Citation

Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000 Jul 4;133(1):21-30. Erratum in: Ann Intern Med 2002 Feb 5;136(3):253. — View Citation

Volmink J, Matchaba P, Garner P. Directly observed therapy and treatment adherence. Lancet. 2000 Apr 15;355(9212):1345-50. Erratum in: Lancet 2000 Jul 29;356(9227):434. — View Citation

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