A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy
Public ClinicalTrials.gov record NCT00004583. 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.
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, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV). Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.
Study identification
- NCT ID
- NCT00004583
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 660 participants
Conditions and interventions
Conditions
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
- Mar 1999 (Type not available)
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Feb 20, 2009
Started 1999
United States locations
- U.S. sites
- 42
- U.S. states
- 24
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 | — |
| Steinhart Medical Associates | Miami | Florida | 33133 | — |
| 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 | — |
| 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 | — |
| East Orange Veterans Administration Med Ctr | East Orange | New Jersey | 07018 | — |
| 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 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 | — |
| Vanderbilt Univ Med Ctr | Nashville | Tennessee | 37203 | — |
| Central Texas Med Foundation | Austin | Texas | 78751 | — |
| Oaklawn Physicians Group | Dallas | Texas | 75219 | — |
| Univ of Texas Southwestern Med Ctr | Dallas | Texas | 75235 | — |
| Joseph C Gathe | Houston | Texas | 77004 | — |
| 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 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00004583, 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 23, 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 public registry record, listed eligibility criteria, and available contact information for NCT00004583 live on ClinicalTrials.gov.