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

NCT00036452 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2021-11-01

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections

Interventions

DRUG

lopinavir/ritonavir

DRUG

emtricitabine

DRUG

stavudine

DRUG

tenofovir DF

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Donna Mildvan, MD · Beth Israel Medical Center

  • Charles Flexner, MD · Johns Hopkins University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2006-01-31

Countries

  • United States
  • Puerto Rico
  • South Africa

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00036452 on ClinicalTrials.gov