MedTrace Logo

Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults

NCT00608569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 529

Last updated 2018-10-12

Study results available
· View outcomes & findings →

Summary

Highly active antiretroviral therapy (HAART) has led to better health and survival rates among people with HIV/AIDS. The purpose of this study was to measure the effect of trained partner supervision when taking medication versus self-administered therapy in HIV infected participants. These participants have had their first virologic failure on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART regimen and were starting a protease inhibitor (PI)-based HAART regimen at study entry.

Conditions

  • HIV Infections

Interventions

DRUG

Lopinavir/ritonavir

Two tablets (200-mg lopinavir and 50 mg ritonavir in each tablet), taken orally twice daily

DRUG

Emtricitabine/Tenofovir disoproxil fumarate

200-mg emtricitabine and 300 mg tenofovir disoproxil fumarate in each tablet, taken orally once daily

DRUG

Tenofovir disoproxil fumarate

300-mg tablet taken orally once daily

DRUG

Zidovudine

300-mg tablet taken orally twice daily

DRUG

Emtricitabine

200-mg tablet taken orally once daily

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • Robert Gross, MD, MSCE · University of Pennsylvania

  • Alberto La Rosa, MD · Asociación Civil Impacta Salud y Educación, Peru

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Botswana
  • Brazil
  • Haiti
  • Peru
  • South Africa
  • Uganda
  • Zambia
  • Zimbabwe

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 NCT00608569 on ClinicalTrials.gov