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Comparative Study of Three NNRTI-Sparing HAART Regimens

NCT00811954 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1814

Last updated 2014-09-05

Study results available
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Summary

The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV infected patients who have never received anti-HIV therapy be treated with a triple drug regimen. The most commonly prescribed and successful regimen contains the medication efavirenz (EFV). However, this regimen may not be an option for everyone, hence alternative regimens are needed.

This study was designed to look at how well different combinations of anti-HIV drugs work to decrease the amount of HIV in the blood (viral load) of and allow immune system recovery in people who have never received anti-HIV therapy. This study also examined drug tolerability and safety for the various drug combinations.

Conditions

  • HIV Infection

Interventions

DRUG

Emtricitabine/tenofovir disoproxil fumarate

200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs).

DRUG

Raltegravir

400 mg taken orally twice daily. An integrase inhibitor (INI).

DRUG

Darunavir

800 mg taken orally once daily. A protease inhibitor (PI).

DRUG

Ritonavir

100 mg taken orally once daily. A protease inhibitor (PI).

DRUG

Atazanavir

300 mg taken orally once daily. A protease inhibitor (PI).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Gilead Sciences

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

    collaborator INDUSTRY

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

    lead NETWORK

Principal Investigators

  • Jeffrey L. Lennox, MD · Emory HIV/AIDS CTU

  • Judith Silverstein Currier, MD, MSc · UCLA AIDS Prevention & Treatment CTU

  • Raphael Landovitz, MD, MSc · UCLA AIDS Prevention & Treatment CTU

  • Igho Ofotokun, MD · Emory HIV/AIDS CTU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

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 NCT00811954 on ClinicalTrials.gov