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

NCT ID: NCT00001122

Last Updated: 2011-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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.

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.

Conditions

HIV Infections

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT

Interventions

Nelfinavir mesylate

Intervention Type: DRUG

Efavirenz

Intervention Type: DRUG

Stavudine

Intervention Type: DRUG

Didanosine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Principal Investigators

Susan Little

Role: PRINCIPAL_INVESTIGATOR

Diane Havlir

Role: PRINCIPAL_INVESTIGATOR

Locations

UCSD

San Diego, California, United States

Univ of Texas Southwestern Med Ctr

Dallas, Texas, United States

Countries

United States

Other Identifiers

AEHIV 003: MAT

Identifier Type: -

Identifier Source: secondary_id

AIEDRP AI-05-003

Identifier Type: -

Identifier Source: org_study_id