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Completed Phase 3 Interventional

A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment

ClinicalTrials.gov ID: NCT00004581

Public ClinicalTrials.gov record NCT00004581. 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 19, 2026, 7:18 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

A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects

Brief summary

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

The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).

Study identification

NCT ID
NCT00004581
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Abbott
Industry
Enrollment
300 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
12 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
Not listed
Primary completion
Not listed
Completion
Not listed
Last update posted
Feb 20, 2009

United States locations

U.S. sites
46
U.S. states
26
U.S. cities
36
Facility City State ZIP Site status
Univ of Alabama at Birmingham Birmingham Alabama 35294 —
Phoenix Body Positive Phoenix Arizona 85016 —
Pacific Oaks Med Group Beverly Hills California 90211 —
Orange County Ctr for Special Immunology Fountain Valley California 92708 —
AIDS Healthcare Foundation Los Angeles California 900276069 —
Tower ID Med Associates Los Angeles California 90048 —
UCLA CARE Ctr Los Angeles California 90095 —
San Francisco Veterans Administration Med Ctr San Francisco California 94121 —
Harbor - UCLA Med Ctr Torrance California 90502 —
Yale Univ / AIDS Clinical Trials Unit New Haven Connecticut 06510 —
Univ of Miami School of Medicine Miami Florida 33136 —
Infectious Disease Research Institute Tampa Florida 33614 —
AIDS Research Consortium of Atlanta Atlanta Georgia 30308 —
Emory Univ Atlanta Georgia 30308 —
Cook County Hosp Chicago Illinois 60612 —
AIDS Research Alliance - Chicago Chicago Illinois 60657 —
Division of Inf Diseases/ Indiana Univ Hosp Indianapolis Indiana 46202 —
Univ of Kansas School of Medicine Wichita Kansas 67214 —
Tulane Univ Med School New Orleans Louisiana 70112 —
Johns Hopkins Hosp Baltimore Maryland 21205 —
Boston Med Ctr Boston Massachusetts 02118 —
Community Research Initiative of New England Brookline Massachusetts 02445 —
Univ of Michigan Hospitals and Health Ctrs Ann Arbor Michigan 481090378 —
Abbott Northwestern Hosp Minneapolis Minnesota 55407 —
Saint Michael's Med Ctr / Dept of Infectious Diseases Newark New Jersey 07102 —
St Michaels Med Ctr Newark New Jersey 07102 —
Beth Israel Med Ctr New York New York 10003 —
Cornell Clinical Trials Unit - Chelsea Clinic New York New York 10011 —
Howard Grossman New York New York 10011 —
SUNY / Health Sciences Ctr at Stony Brook Stony Brook New York 117948153 —
SUNY at Stony Brook / Div of Infectious Disease Stony Brook New York 117948153 —
Duke Univ Med Ctr / Infectious Disease Clinic Durham North Carolina 27710 —
Holmes Hosp / Univ of Cincinnati Med Ctr Cincinnati Ohio 452670405 —
Associates in Med and Mental Health Tulsa Oklahoma 74114 —
Oregon Health Sciences Univ Portland Oregon 972109951 —
Philadelphia FIGHT Philadelphia Pennsylvania 19107 —
Stephen Hauptman Philadelphia Pennsylvania 19107 —
The Miriam Hosp Providence Rhode Island 02906 —
Oaklawn Physicians Group Dallas Texas 75219 —
Univ of Texas Southwestern Med Ctr Dallas Texas 75235 —
Univ of Texas / Med Branch at Galveston Galveston Texas 775550835 —
Joseph C Gathe Houston Texas 77004 —
Univ of Utah Med School / Clinical Trials Ctr Salt Lake City Utah 84108 —
Infectious Disease Physicians Inc Annandale Virginia 22203 —
Univ of Virginia Health Sciences Ctr Charlottesville Virginia 22908 —
Univ of Wisconsin Madison Wisconsin 53792 —

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 42 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00004581, 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 Feb 20, 2009 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00004581 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →