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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00036452
First received: May 10, 2002
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: lopinavir/ritonavir
Drug: emtricitabine
Drug: stavudine
Drug: tenofovir DF
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 402
Study Completion Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036452

  Hide Study Locations
Locations
United States, California
USC CRS
Los Angeles, California, United States, 90033-1079
Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, United States
Ucsd, Avrc Crs
San Diego, California, United States, 92103
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80262
United States, Florida
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136
United States, Hawaii
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816-2396
United States, Indiana
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202-5250
United States, Maryland
IHV Baltimore Treatment CRS
Baltimore, Maryland, United States, 21201
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
United States, Massachusetts
SSTAR, Family Healthcare Ctr.
Fall River, Massachusetts, United States
United States, Minnesota
University of Minnesota, ACTU
Minneapolis, Minnesota, United States, 55455-0392
United States, New York
Beth Israel Med. Ctr., ACTU
New York, New York, United States, 10003
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
AIDS Care CRS
Rochester, New York, United States, 14642-0001
McCree McCuller Wellness Ctr. at the Connection, Infectious Disease Unit
Rochester, New York, United States, 14642-0001
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14215
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27514
Regional Center for Infectious Disease, Wendover Medical Center CRS
Greensboro, North Carolina, United States, 27401-1004
Wake County Health and Human Services CRS
Raleigh, North Carolina, United States
United States, Ohio
Univ. of Cincinnati CRS
Cincinnati,, Ohio, United States, 45267-0405
MetroHealth CRS
Cleveland, Ohio, United States, 44109-1998
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
United States, Pennsylvania
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
Pitt CRS
Pittsburgh, Pennsylvania, United States, 15213-2582
United States, Rhode Island
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Therapeutics CRS
Nashville, Tennessee, United States, 37203
United States, Washington
University of Washington AIDS CRS
Seattle, Washington, United States, 98104
Puerto Rico
Puerto Rico-AIDS CRS
San Juan, Puerto Rico, 00936-5067
South Africa
Wits HIV CRS
Johannesburg, Gauteng, South Africa
Sponsors and Collaborators
Investigators
Study Chair: Donna Mildvan, MD Beth Israel Medical Center
Study Chair: Charles Flexner, MD Johns Hopkins University Hospital
  More Information

Additional Information:
Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00036452     History of Changes
Other Study ID Numbers: A5073, 10073, ACTG A5073, AACTG A5073
Study First Received: May 10, 2002
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Emtricitabine
Lopinavir
Reverse Transcriptase Inhibitors
Ritonavir
Stavudine
Tenofovir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014