A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
Public ClinicalTrials.gov record NCT00002378. 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 Phase IIIB Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule (SGC) BID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule (SGC) BID Plus Nelfinavir BID Plus a NRTI in HIV-1 Infected Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\< 400 copies/ml) at week 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment. To collect safety data on the treatment regimens. AS PER AMENDMENT 12/12/97: To compare the virologic response of Fortovase (FTV) (Saquinavir) Soft Gel Capsule (SGC) tid plus nucleoside reverse transcriptase inhibitors (NRTIs) versus FTV bid plus NRTIs. Further, to compare the virologic response of FTV tid plus NRTIs versus FTV bid plus Nelfinavir bid plus a NRTI with respect to: the percentage of patients whose plasma HIV-1 RNA level falls below the Amplicor assay level of detection (\< 400 copies/ml) at week 24 and week 48.
Study identification
- NCT ID
- NCT00002378
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 825 participants
Conditions and interventions
Conditions
Interventions
- Ritonavir Drug
- Nelfinavir mesylate Drug
- Saquinavir Drug
- Delavirdine mesylate Drug
- Lamivudine Drug
- Stavudine Drug
- Zidovudine Drug
Drug
Eligibility (public fields only)
- Age range
- 16 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
- Jun 24, 2005
United States locations
- U.S. sites
- 97
- U.S. states
- 28
- U.S. cities
- 66
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ASC Inc | Anniston | Alabama | 36201 | — |
| CIGNA | Phoenix | Arizona | 85006 | — |
| Arizona Clinical Research Ctr Inc | Tucson | Arizona | 85712 | — |
| Univ of Arizona | Tucson | Arizona | 85724 | — |
| Alta Bates Med Ctr | Berkeley | California | 94705 | — |
| Ctr for Special Immunology | Irvington District | California | 92718 | — |
| AIDS Healthcare Foundation Labs | Los Angeles | California | 90027 | — |
| Beer Med Group | Los Angeles | California | 90036 | — |
| Dr Charles Farthing | Los Angeles | California | 90048 | — |
| Gottlieb Med Group | North Hollywood | California | 91607 | — |
| Dr Wilbert Jordan | Paramount | California | 90723 | — |
| AIDS Community Research Consortium | Redwood City | California | 94063 | — |
| Dr Daniel Pearce | San Francisco | California | 92101 | — |
| UCSF - San Francisco Gen Hosp | San Francisco | California | 94110 | — |
| Kaiser Permanente Med Ctr | San Francisco | California | 94115 | — |
| QUEST Clinical Research | San Francisco | California | 94115 | — |
| Marin County Specialty Clinic | San Rafael | California | 94903 | — |
| Shared Med Research Foundation | Tarzana | California | 91356 | — |
| Denver Public Health Dept / Disease Control Services | Denver | Colorado | 80204 | — |
| Kaiser Permanente, Infectious Disease | Denver | Colorado | 80205 | — |
| Georgetown Univ Med Ctr | Washington D.C. | District of Columbia | 20007 | — |
| Anderson Clinical Research | Washington D.C. | District of Columbia | 20037 | — |
| Providence Hosp | Washington D.C. | District of Columbia | 20037 | — |
| IDC Research Initiative | Altamonte Springs | Florida | 32701 | — |
| Urgent Care Ctr | Fort Lauderdale | Florida | 33316 | — |
| Stratogen of Ft Lauderdale | Fort Lauderdale | Florida | 33334 | — |
| Dr Robert Schwartz | Fort Myers | Florida | 33901 | — |
| Duval County Health Dept | Jacksonville | Florida | 32206 | — |
| Steinhart Medical Associates | Miami | Florida | 33133 | — |
| Stratogen Health of Palm Beach | Palm Beach Gardens | Florida | 33410 | — |
| Ctr for Quality Care | Tampa | Florida | 33609 | — |
| Univ of South Florida | Tampa | Florida | 33612 | — |
| Infectious Disease Research Institute Inc | Tampa | Florida | 33614 | — |
| Treasure Coast Infectious Disease Consultants | Vero Beach | Florida | 32960 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | — |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | 30033 | — |
| Northwestern Univ Med Ctr | Chicago | Illinois | 60611 | — |
| SIU School of Medicine | Springfield | Illinois | 62702 | — |
| Carle Clinic Association | Urbana | Illinois | 61801 | — |
| Indiana Univ Hosp | Indianapolis | Indiana | 462025250 | — |
| Univ of Kentucky / Kentucky Clinic Annex # | Lexington | Kentucky | 40536 | — |
| Community Research Initiative | Brookline | Massachusetts | 02445 | — |
| Univ of Massachusetts Med Ctr | Worcester | Massachusetts | 01655 | — |
| Harper Hosp | Detroit | Michigan | 48201 | — |
| Saint Joseph's / Mercy Hosp | Ypsilanti | Michigan | 48197 | — |
| Abbott Northwestern Hosp | Minneapolis | Minnesota | 55407 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Univ of Missouri at Kansas City School of Medicine | Kansas City | Missouri | 64108 | — |
| Antibiotic Research Associates | Kansas City | Missouri | 64132 | — |
| HIV Wellness Ctr / Univ Med Ctr | Las Vegas | Nevada | 89102 | — |
| Dartmouth-Hitchcock Med Ctr | Lebanon | New Hampshire | 03756 | — |
| UMDNJ - New Jersey Med School / Cooper Hosp | Camden | New Jersey | 08103 | — |
| VAMC New Jersey Healthcare System | East Orange | New Jersey | 07018 | — |
| New Jersey Community Research Initiative | Newark | New Jersey | 07103 | — |
| St Joseph's Hosp & Med Center | Paterson | New Jersey | 07503 | — |
| Albany Med College / Division of HIV Medicine A158 | Albany | New York | 122083479 | — |
| Brookdale Univ Med Ctr | Brooklyn | New York | 11212 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Nassau County Med Ctr | East Meadow | New York | 11554 | — |
| Elmhurst Hosp | Elmhurst | New York | 11373 | — |
| North Shore Univ Hosp | Manhasset | New York | 11030 | — |
| Mt Vernon Hosp | Mount Vernon | New York | 10550 | — |
| Dr Michael Mullen | New York | New York | 10003 | — |
| Peter Krueger Clinic | New York | New York | 10003 | — |
| Howard Grossman | New York | New York | 10011 | — |
| AIDS Clinical Trials Unit | New York | New York | 10016 | — |
| Dr Douglas Dieterich | New York | New York | 10016 | — |
| Dr Ron Grossman | New York | New York | 10016 | — |
| Liberty Med Group | New York | New York | 10016 | — |
| St Lukes / Roosevelt Hosp / HIV Center | New York | New York | 10019 | — |
| New York / Cornell Med Ctr | New York | New York | 10021 | — |
| New York Hosp - Cornell Med Ctr | New York | New York | 10021 | — |
| New York Hosp / Cornell Med Ctr | New York | New York | 10021 | — |
| Harlem Hosp Ctr | New York | New York | 10037 | — |
| Montefiore Med Ctr | The Bronx | New York | 10467 | — |
| Carolinas Research Associates | Charlotte | North Carolina | 28203 | — |
| Nalle Clinic | Charlotte | North Carolina | 28207 | — |
| East Carolina Univ School of Medicine | Greenville | North Carolina | 27858 | — |
| Bowman Gray School of Medicine | Winston-Salem | North Carolina | 27157 | — |
| Univ of Cincinnati Med Ctr / Holmes Division | Cincinnati | Ohio | 45267 | — |
| Oklahoma Univ Health Science Ctr | Oklahoma City | Oklahoma | 73104 | — |
| Lehigh Valley Hosp | Allentown | Pennsylvania | 18105 | — |
| Allegheny Univ Hosp | Philadelphia | Pennsylvania | 19129 | — |
| Dr Jay Kostman | Philadelphia | Pennsylvania | 19140 | — |
| Roger Williams Med Ctr | Providence | Rhode Island | 02908 | — |
| Burnside Clinic | Columbia | South Carolina | 29206 | — |
| Austin Infectious Disease Consultants | Austin | Texas | 78705 | — |
| Dr Nicholaos Bellos | Dallas | Texas | 75225 | — |
| Univ of Texas Southwestern Med Ctr of Dallas | Dallas | Texas | 75235 | — |
| North Texas Infectious Disease Consultants | Dallas | Texas | 75246 | — |
| Houston Clinical Research Network | Houston | Texas | 77004 | — |
| ONCOL Med Associates / PA | Houston | Texas | 77027 | — |
| Houston Med Ctr | Houston | Texas | 77030 | — |
| Houston Clinical Research Network | Houston | Texas | 77098 | — |
| Infectious Disease Physicians Inc | Annandale | Virginia | 22203 | — |
| Swedish Med Ctr / Dr Peter Shalit | Seattle | Washington | 98104 | — |
| Aurora Med Group | Milwaukee | Wisconsin | 53212 | — |
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 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00002378, 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 Jun 24, 2005 · Synced Oct 19, 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 NCT00002378 live on ClinicalTrials.gov.