Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Didanosine
Efavirenz
Nelfinavir
Stavudine
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.