Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
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 Sep 2, 2026, 4:37 PM 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 19, 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 19, 2009 · Synced Sep 2, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00004581 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →