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

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

402

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Donna Mildvan, MD, Beth Israel Medical Center
  • Study Chair: Charles Flexner, MD, Johns Hopkins University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

May 10, 2002

First Submitted That Met QC Criteria

May 10, 2002

First Posted (Estimate)

May 13, 2002

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5073
  • 10073 (Registry Identifier: DAIDS ES)
  • ACTG A5073
  • AACTG A5073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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