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Completed Phase 3 Interventional Results available

Comparative Study of Three NNRTI-Sparing HAART Regimens

ClinicalTrials.gov ID: NCT00811954

Public ClinicalTrials.gov record NCT00811954. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 3:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The ARDENT Study: Atazanavir, Raltegravir, or Darunavir With Emtricitabine/Tenofovir for Naive Treatment

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00811954
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
1,814 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2009 (Type not available)
Primary completion
Jun 2013 (Actual)
Completion
Jun 2013 (Actual)
Last update posted
Sep 5, 2014

2009 – 2013

United States locations

U.S. sites
55
U.S. states
23
U.S. cities
42
Facility City State ZIP Site status
Alabama Therapeutics CRS Birmingham Alabama 35294-2050 —
Miller Children's Hospital Long Beach California 90806 —
USC CRS Los Angeles California 90033 —
UCLA CARE Center CRS Los Angeles California 90035 —
Stanford CRS Palo Alto California 94304 —
Ucsd, Avrc Crs San Diego California 92103 —
Ucsf Aids Crs San Francisco California 94110 —
Harbor-UCLA Med. Ctr. CRS Torrance California 90502 —
University of Colorado Hospital CRS Aurora Colorado 80045 —
Denver Public Health CRS Denver Colorado 80204 —
Georgetown University CRS (GU CRS) Washington D.C. District of Columbia 20007 —
Howard Univ. Washington DC NICHD CRS Washington D.C. District of Columbia 20060 —
South Florida Childrens Diagnostic & Treatment Cen (5055) Fort Lauderdale Florida 33316 —
University of Florida Jacksonville (5051) Jacksonville Florida 32209 —
Univ. of Miami AIDS CRS Miami Florida 33136 —
The Ponce de Leon Center CRS Atlanta Georgia 30308 —
Northwestern University CRS Chicago Illinois 60611 —
Rush Univ. Med. Ctr. ACTG CRS Chicago Illinois 60612 —
Tulane University New Orleans NICHD CRS (5095) New Orleans Louisiana 70112 —
IHV Baltimore Treatment CRS Baltimore Maryland 21201 —
Johns Hopkins Adult AIDS CRS Baltimore Maryland 21287 —
Massachusetts General Hospital CRS Boston Massachusetts 02114 —
Brigham and Women's Hosp. ACTG CRS Boston Massachusetts 02115 —
Bmc Actg Crs Boston Massachusetts 02118 —
Beth Israel Deaconess Med. Ctr., ACTG CRS Boston Massachusetts 02215 —
Wayne State Univ. CRS Detroit Michigan 48201 —
Henry Ford Hosp. CRS Detroit Michigan 48202 —
Washington U CRS St Louis Missouri 63110 —
Cooper Univ. Hosp. CRS Camden New Jersey 08103 —
New Jersey Medical School- Adult Clinical Research Ctr. CRS Newark New Jersey 07103 —
Cornell CRS New York New York 10011 —
NY Univ. HIV/AIDS CRS New York New York 10016 —
Metropolitan Hospital New York New York 10029 —
HIV Prevention & Treatment CRS New York New York 10032 —
AIDS Care CRS Rochester New York 14607 —
Univ. of Rochester ACTG CRS Rochester New York 14642 —
SUNY Stony Brook NICHD CRS (5040) Stony Brook New York 11794 —
Bronx-Lebanon Hosp. Ctr. CRS The Bronx New York 10457 —
Unc Aids Crs Chapel Hill North Carolina 27514 —
Duke Univ. Med. Ctr. Adult CRS Durham North Carolina 27710 —
Regional Center for Infectious Disease, Wendover Medical Center CRS (3203) Greensboro North Carolina 27401 —
Univ. of Cincinnati CRS Cincinnati Ohio 45267 —
Case CRS Cleveland Ohio 44106 —
Metro Health CRS Cleveland Ohio 44109 —
The Ohio State Univ. AIDS CRS Columbus Ohio 43210 —
The Research & Education Group- Portland CRS (31474) Portland Oregon 97209 —
Hosp. of the Univ. of Pennsylvania CRS Philadelphia Pennsylvania 19104 —
Pitt CRS Pittsburgh Pennsylvania 15213 —
The Miriam Hosp. ACTG CRS Providence Rhode Island 02906 —
St. Jude/UTHSC CRS Memphis Tennessee 38105-2794 —
Vanderbilt Therapeutics CRS Nashville Tennessee 37203 —
Trinity Health and Wellness Center Dallas Texas 75208 —
Houston AIDS Research Team CRS Houston Texas 77030 —
Virginia Commonwealth Univ. Medical Ctr. CRS Richmond Virginia 23219 —
University of Washington AIDS CRS Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00811954, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 5, 2014 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00811954 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →