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Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection

NCT00414518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-02-20

Study results available
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Summary

The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug regimen followed by treatment interruption in people recently infected with HIV. This study will also compare the effects of a treatment regimen including treatment interruption with a treatment plan based on clinical indicators.

Conditions

  • HIV Infections

Interventions

DRUG

Tenofovir disoproxil fumarate/Emtricitabine

300 mg Tenofovir disoproxil fumarate/ 200 mg emtricitabine tablet taken orally once daily

DRUG

Lopinavir/Ritonavir

Three 400 mg lopinavir/ 100 mg ritonavir soft gel capsules taken orally twice daily

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Michelle A. Barron, MD · Division of Infectious Disease, University of Colorado Health Sciences Center

  • Margaret Borok, MRCP · Department of Medicine, University of Zimbabwe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States
  • Zimbabwe

Study Locations

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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 NCT00414518 on ClinicalTrials.gov