A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
Public ClinicalTrials.gov record NCT00000841. 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 Indinavir Sulfate With Open-Label Zidovudine (AZT) and Lamivudine (3TC) in Subjects With HIV Infection With CD4 Cell Counts <= 200 Cells/mm3 and >= 6 Months of Prior AZT Experience
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients. Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.
Study identification
- NCT ID
- NCT00000841
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,750 participants
Conditions and interventions
Conditions
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
- Not listed
- Primary completion
- Not listed
- Completion
- Jun 1997 (Actual)
- Last update posted
- Nov 4, 2021
Ends 1997
United States locations
- U.S. sites
- 85
- U.S. states
- 25
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Children's Hosp of Los Angeles | Los Angeles | California | 90027 | — |
| Univ of Southern California / LA County USC Med Ctr | Los Angeles | California | 900331079 | — |
| UCLA CARE Ctr | Los Angeles | California | 90095 | — |
| Univ of California / San Diego Treatment Ctr | San Diego | California | 921036325 | — |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | San Francisco | California | 941102859 | — |
| San Francisco Gen Hosp | San Francisco | California | 941102859 | — |
| Stanford at Kaiser / Kaiser Permanente Med Ctr | San Francisco | California | 94115 | — |
| San Mateo AIDS Program / Stanford Univ | Stanford | California | 943055107 | — |
| Stanford Univ Med Ctr | Stanford | California | 943055107 | — |
| Harbor UCLA Med Ctr | Torrance | California | 90502 | — |
| Kaiser Permanente Franklin Med Ctr | Denver | Colorado | 80262 | — |
| Mountain States Reg Hemo Ctr / Univ of Colorado | Denver | Colorado | 80262 | — |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | — |
| George Washington Univ / Hershey Med Ctr | Washington D.C. | District of Columbia | 20037 | — |
| Georgetown Univ Hosp | Washington D.C. | District of Columbia | 20037 | — |
| Howard Univ | Washington D.C. | District of Columbia | 20059 | — |
| Univ of Miami School of Medicine | Miami | Florida | 331361013 | — |
| Univ of Miami (Pediatric) | Miami | Florida | 33161 | — |
| Emory Univ | Atlanta | Georgia | 30308 | — |
| Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr | Atlanta | Georgia | 303652225 | — |
| Queens Med Ctr | Honolulu | Hawaii | 96816 | — |
| Univ of Hawaii | Honolulu | Hawaii | 96816 | — |
| Northwestern Univ Med School | Chicago | Illinois | 60611 | — |
| Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois | 60612 | — |
| Chicago Children's Memorial Hosp | Chicago | Illinois | 606143394 | — |
| Louis A Weiss Memorial Hosp | Chicago | Illinois | 60640 | — |
| Illinois Masonic Med Ctr | Chicago | Illinois | 606575147 | — |
| Indiana Univ Hosp | Indianapolis | Indiana | 462025250 | — |
| Division of Inf Diseases/ Indiana Univ Hosp | Indianapolis | Indiana | 46202 | — |
| Methodist Hosp of Indiana / Life Care Clinic | Indianapolis | Indiana | 46202 | — |
| Univ of Iowa Hosp and Clinic | Iowa City | Iowa | 52242 | — |
| Charity Hosp / Tulane Univ Med School | New Orleans | Louisiana | 70112 | — |
| Tulane Med Ctr Hosp | New Orleans | Louisiana | 70112 | — |
| Tulane Univ School of Medicine | New Orleans | Louisiana | 70112 | — |
| State of MD Div of Corrections / Johns Hopkins Univ Hosp | Baltimore | Maryland | 212052196 | — |
| Johns Hopkins Hosp | Baltimore | Maryland | 21287 | — |
| Harvard (Massachusetts Gen Hosp) | Boston | Massachusetts | 02114 | — |
| Boston Med Ctr | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess - West Campus | Boston | Massachusetts | 02215 | — |
| Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial | Worcester | Massachusetts | 01605 | — |
| Hennepin County Med Clinic | Minneapolis | Minnesota | 55415 | — |
| Univ of Minnesota | Minneapolis | Minnesota | 55455 | — |
| St Paul Ramsey Med Ctr | Saint Paul | Minnesota | 55101 | — |
| St Louis Regional Hosp / St Louis Regional Med Ctr | St Louis | Missouri | 63112 | — |
| Univ of Nebraska Med Ctr | Omaha | Nebraska | 681985130 | — |
| SUNY / Erie County Med Ctr at Buffalo | Buffalo | New York | 14215 | — |
| North Shore Univ Hosp | Great Neck | New York | 11021 | — |
| Beth Israel Med Ctr | New York | New York | 10003 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Kaplan Cancer Ctr / New York Univ Med Ctr | New York | New York | 10016 | — |
| Manhattan Veterans Administration / New York Univ Med Ctr | New York | New York | 10016 | — |
| Saint Clare's Hosp and Health Ctr | New York | New York | 10019 | — |
| Cornell Univ Med Ctr | New York | New York | 10021 | — |
| Mem Sloan - Kettering Cancer Ctr | New York | New York | 10021 | — |
| St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr | New York | New York | 10021 | — |
| Mount Sinai Med Ctr / Hemophilia Treatment Ctr | New York | New York | 10029 | — |
| Mount Sinai Med Ctr / Pediatrics | New York | New York | 10029 | — |
| Mount Sinai Med Ctr | New York | New York | 10029 | — |
| Harlem Hosp Ctr | New York | New York | 10037 | — |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | — |
| SUNY / State Univ of New York | Syracuse | New York | 13210 | — |
| Montefiore Med Ctr Adolescent AIDS Program | The Bronx | New York | 10467 | — |
| Bronx Veterans Administration / Mount Sinai Hosp | The Bronx | New York | 10468 | — |
| Univ of North Carolina | Chapel Hill | North Carolina | 275997215 | — |
| Carolinas Med Ctr | Charlotte | North Carolina | 28203 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 27710 | — |
| Moses H Cone Memorial Hosp | Greensboro | North Carolina | 27401 | — |
| Central Prison/Women's Prison in Raleigh / NC | Raleigh | North Carolina | 276260540 | — |
| Univ of Cincinnati | Cincinnati | Ohio | 452670405 | — |
| Univ of Kentucky Lexington | Cincinnati | Ohio | 45267 | — |
| Case Western Reserve Univ | Cleveland | Ohio | 44106 | — |
| Columbus Children's Hosp | Columbus | Ohio | 432052696 | — |
| Ohio State Univ Hosp Clinic | Columbus | Ohio | 432101228 | — |
| Milton S Hershey Med Ctr | Hershey | Pennsylvania | 170330850 | — |
| Thomas Jefferson Univ Hosp | Philadelphia | Pennsylvania | 191075098 | — |
| Med Univ of South Carolina | Charleston | South Carolina | 294253312 | — |
| Julio Arroyo | West Columbia | South Carolina | 29169 | — |
| Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr | Knoxville | Tennessee | 37920 | — |
| Meharry Med College | Nashville | Tennessee | 37203 | — |
| Vanderbilt Univ Med Ctr | Nashville | Tennessee | 37203 | — |
| Univ of Texas Galveston | Galveston | Texas | 775550435 | — |
| Univ Texas Health Science Ctr / Univ Texas Med School | Houston | Texas | 77030 | — |
| Univ of Washington | Seattle | Washington | 981224304 | — |
| Great Lakes Hemophilia Foundation | Wauwatosa | Wisconsin | 532130127 | — |
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 NCT00000841, 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 Nov 4, 2021 · Synced Oct 22, 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 NCT00000841 live on ClinicalTrials.gov.