Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001122
First received: November 2, 1999
Last updated: March 1, 2011
Last verified: January 2005
  Purpose

The purpose of this study is to see if observed therapy can help HIV-positive patients stick to their anti-HIV medication schedule. Observed therapy means that a nurse will watch patients take their medications to make sure that they take them correctly.

It is very important that HIV-positive patients take their anti-HIV medications correctly so they get the best possible benefit from them. Taking the drugs correctly, called "adherence," may keep HIV virus levels in the blood (viral load) low for a longer time. Adherence can also slow the development of drug resistance, and this is especially important in patients with early HIV infection who are just beginning treatment. However, anti-HIV medication schedules are often complicated, and many patients have difficulty remembering to take their drugs at the correct time. This study will look at the effectiveness of a plan to help patients with this problem.


Condition Intervention Phase
HIV Infections
Drug: Nelfinavir mesylate
Drug: Efavirenz
Drug: Stavudine
Drug: Didanosine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Open-Label Study of Maximally Assisted Therapy (MAT) Compared to Self-Administered Therapy (SAT) for the Treatment of HIV Infection in Antiretroviral Naive Subjects With CD4 Greater Than or Equal to 200 Cells/mm3

Resource links provided by NLM:


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

Estimated Enrollment: 74
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Detailed Description:

Novel approaches are needed to improve adherence to combination antiretroviral therapy. Nonadherence can lead to reduced drug levels and inadequate viral suppression, which accelerates drug resistance. Thus nonadherence in the first few months of primary HIV infection can limit therapeutic options for an individual years later. Barriers to optimal treatment adherence in patients with early HIV infection include complex treatment regimens which disrupt daily routines, drug intolerance, and concomitant illness including depression. Directly observed therapy has been successful in improving overall effectiveness of antituberculosis therapy and may be a useful strategy in HIV-infected patients.

All patients receive combination antiretroviral therapy with didanosine (ddI), stavudine (d4T), efavirenz (EFV), and nelfinavir (NFV). Patients are randomized to self-administered (SAT) versus observed (MAT) therapy for 24 weeks. Patients randomized to MAT receive one directly observed dose (ddI, d4T, EFV, and NFV) of their antiretroviral regimen by a field worker or nurse at the clinic 5 days per week. As a reminder for the second NFV and d4T dose, MAT patients are provided with an alarm watch programmed to sound at dosing times. The alarm watch also serves as a reminder for weekend doses that will not be directly observed. Patients randomized to SAT receive standard care. All patients are monitored with monthly plasma HIV RNA levels and CD4 and CD8 cell counts. At Week 24, all patients are crossed over to SAT for an additional 48 weeks of follow-up.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Are at least 13 years old (consent is required if you are under 18).
  • Have a CD4 count of at least 200 cells/mm3 within 30 days of study entry.
  • Have never taken anti-HIV drugs.
  • Agree to practice effective methods of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have cancer (except for Kaposi's sarcoma) that requires treatment.
  • Have a history of hepatitis or pancreatitis.
  • Have peripheral neuropathy.
  • Have an alcohol abuse problem.
  • Are pregnant or breast-feeding.
  • Are taking certain medications, such as rifabutin, rifampin, interleukin, or chemotherapy.
  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: NCT00001122

Locations
United States, California
UCSD
San Diego, California, United States, 92103
United States, Texas
Univ of Texas Southwestern Med Ctr
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Investigators
Principal Investigator: Susan Little
Principal Investigator: Diane Havlir
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00001122     History of Changes
Other Study ID Numbers: AIEDRP AI-05-003, AEHIV 003: MAT
Study First Received: November 2, 1999
Last Updated: March 1, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Didanosine
Drug Therapy, Combination
Stavudine
HIV Protease Inhibitors
CD4 Lymphocyte Count
Nelfinavir
Reverse Transcriptase Inhibitors
Self Care
Anti-HIV Agents
Viral Load
efavirenz
Treatment Naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
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
Didanosine
Efavirenz
Nelfinavir
Reverse Transcriptase Inhibitors
Stavudine
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