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

NCT00036452 | Completed Phase 2

• 4 other identifiers: A507310073ACTG A5073AACTG A5073
• Study Type: interventional
• Target: 402
• Locations: 3 countries
• Sites: 29

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.

Conditions

HIV Infections

Keywords

Lopinavir; HIV-1; Drug Administration Schedule; Stavudine; HIV Protease Inhibitors; Ritonavir; Reverse Transcriptase Inhibitors; Self Care; Viral Load; Emtricitabine; Directly Observed Therapy; Tenofovir Disoproxil Fumarate; Treatment Naive

Interventions

lopinavir/ritonavir DRUG

emtricitabine DRUG

stavudine DRUG

tenofovir DF DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (29)

USC CRS

Los Angeles, California, 90033-1079, United States

Location

Univ. of California Davis Med. Ctr., ACTU

Sacramento, California, United States

Location

Ucsd, Avrc Crs

San Diego, California, 92103, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80262, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, 33136, United States

Location

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, 96816-2396, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 46202-5250, United States

Location

IHV Baltimore Treatment CRS

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

SSTAR, Family Healthcare Ctr.

Fall River, Massachusetts, United States

Location

University of Minnesota, ACTU

Minneapolis, Minnesota, 55455-0392, United States

Location

Beth Israel Med. Ctr., ACTU

New York, New York, 10003, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14215, United States

Location

AIDS Care CRS

Rochester, New York, 14642-0001, United States

Location

McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit

Rochester, New York, 14642-0001, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27514, United States

Location

Regional Center for Infectious Disease, Wendover Medical Center CRS

Greensboro, North Carolina, 27401-1004, United States

Location

Wake County Health and Human Services CRS

Raleigh, North Carolina, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 45267-0405, United States

Location

MetroHealth CRS

Cleveland, Ohio, 44109-1998, United States

Location

The Ohio State Univ. AIDS CRS

Columbus, Ohio, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Pitt CRS

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

The Miriam Hosp. ACTG CRS

Providence, Rhode Island, 02906, United States

Location

Vanderbilt Therapeutics CRS

Nashville, Tennessee, 37203, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98104, United States

Location

Puerto Rico-AIDS CRS

San Juan, 00936-5067, Puerto Rico

Location

Wits HIV CRS

Johannesburg, Gauteng, South Africa

Location

Related Publications (7)

• 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. doi: 10.7326/0003-4819-134-10-200105150-00011.

  PMID: 11352698 BACKGROUND

• 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. doi: 10.7326/0003-4819-133-1-200007040-00004.

  PMID: 10877736 BACKGROUND

• Volmink J, Matchaba P, Garner P. Directly observed therapy and treatment adherence. Lancet. 2000 Apr 15;355(9212):1345-50. doi: 10.1016/S0140-6736(00)02124-3.

  PMID: 10776760 BACKGROUND

• 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. doi: 10.1016/s0002-9343(01)00729-x. No abstract available.

  PMID: 11382379 BACKGROUND

• 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. doi: 10.1086/338400. Epub 2002 Jan 4.

  PMID: 11797179 BACKGROUND

• 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 compared with self-administered therapy in treatment-naive HIV-1-infected patients: a randomized trial. Arch Intern Med. 2009 Jul 13;169(13):1224-32. doi: 10.1001/archinternmed.2009.172.

  PMID: 19597072 RESULT

• 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 antiretroviral therapy in treatment-naive patients: results of AIDS clinical trials group (ACTG) A5073, a 48-week randomized controlled trial. Clin Infect Dis. 2010 Apr 1;50(7):1041-52. doi: 10.1086/651118.

  PMID: 20192725 RESULT

MeSH Terms

Conditions

HIV Infections; Directly Observed Therapy

Interventions

Lopinavir; Emtricitabine; Stavudine; Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Thymidine; Dideoxynucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Donna Mildvan, MD

  Beth Israel Medical Center

  STUDY CHAIR

• Charles Flexner, MD

  Johns Hopkins University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2002
• First Posted: May 13, 2002
• Study Completion: January 1, 2006
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (27); PR (1); ZA (1)