A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment
Public ClinicalTrials.gov record NCT00000671. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in patients with AIDS or advanced AIDS-related complex (ARC) who have tolerated AZT therapy for 12 months or longer. Per amendment, asymptomatic patients with CD4 counts less than 200 cells/mm3 are eligible. AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication of HIV with less apparent toxicity than AZT. Studies indicate that ddI remains active in the body for at least 12 hours; thus benefits of ddI might be achieved with a low frequency of drug administration.
Study identification
- NCT ID
- NCT00000671
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 750 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
- Not listed
- Primary completion
- Feb 29, 1992
- Completion
- Not listed
- Last update posted
- Mar 13, 2011
United States locations
- U.S. sites
- 70
- U.S. states
- 21
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hosp of Los Angeles/UCLA Med Ctr | Los Angeles | California | 900276016 | — |
| Los Angeles County - USC Med Ctr | Los Angeles | California | 90033 | — |
| Cedars Sinai / UCLA Med Ctr | Los Angeles | California | 900481804 | — |
| UCLA CARE Ctr | Los Angeles | California | 90095 | — |
| Harbor - UCLA Med Ctr / UCLA School of Medicine | Los Angeles | California | 905022004 | — |
| Palo Alto Veterans Adm Med Ctr / Stanford Univ | Palo Alto | California | 94304 | — |
| Univ of California / San Diego Treatment Ctr | San Diego | California | 921036325 | — |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | San Francisco | California | 941102859 | — |
| Stanford at Kaiser / Kaiser Permanente Med Ctr | San Francisco | California | 94115 | — |
| Stanford Univ School of Medicine | Stanford | California | 94305 | — |
| Olive View Med Ctr | Sylmar | California | 91342 | — |
| Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr | Sylmar | California | 91342 | — |
| Harbor UCLA Med Ctr | Torrance | California | 90502 | — |
| Mountain States Regional Hemophilia Ctr / Univ of Colorado | Denver | Colorado | 80262 | — |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | — |
| George Washington Univ Med Ctr | Washington D.C. | District of Columbia | 20037 | — |
| G E Morey Jr | Fort Lauderdale | Florida | 33316 | — |
| Univ of Miami School of Medicine | Miami | Florida | 331361013 | — |
| Northwestern Univ Med School | Chicago | Illinois | 60611 | — |
| Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois | 60612 | — |
| Edward Hines Veterans Administration Hosp | Hines | Illinois | 60141 | — |
| Indiana Univ Hosp | Indianapolis | Indiana | 462025250 | — |
| Univ of Kansas School of Medicine | Wichita | Kansas | 67214 | — |
| Louisiana Comprehensive Hemophilia Care Ctr | New Orleans | Louisiana | 70112 | — |
| Louisiana State Univ Med Ctr / Tulane Med School | New Orleans | Louisiana | 70112 | — |
| Tulane Univ School of Medicine | New Orleans | Louisiana | 70112 | — |
| Harvard (Massachusetts Gen Hosp) | Boston | Massachusetts | 02114 | — |
| Boston Med Ctr | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess - West Campus | Boston | Massachusetts | 02215 | — |
| Beth Israel Deaconess Med Ctr | Boston | Massachusetts | 02215 | — |
| Baystate Med Ctr of Springfield | Springfield | Massachusetts | 01199 | — |
| Med Ctr of Central Massachusetts | Worcester | Massachusetts | 01605 | — |
| Univ of Massachusetts Med Ctr | Worcester | Massachusetts | 01655 | — |
| Univ of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Nebraska Regional Hemophilia Ctr | Omaha | Nebraska | 68105 | — |
| SUNY / Erie County Med Ctr at Buffalo | Buffalo | New York | 14215 | — |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | Elmhurst | New York | 11373 | — |
| Beth Israel Med Ctr / Peter Krueger Clinic | New York | New York | 10003 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Cornell Univ Med Ctr | New York | New York | 10021 | — |
| Mem Sloan - Kettering Cancer Ctr | New York | New York | 10021 | — |
| Saint Luke's - Roosevelt Hosp Ctr | New York | New York | 10025 | — |
| Mount Sinai Hemophilia Ctr / Mount Sinai Med Ctr | New York | New York | 10029 | — |
| Mount Sinai Med Ctr | New York | New York | 10029 | — |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | — |
| SUNY - Stony Brook | Stony Brook | New York | 117948153 | — |
| SUNY / State Univ of New York | Syracuse | New York | 13210 | — |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | The Bronx | New York | 10461 | — |
| Jack Weiler Hosp / Bronx Municipal Hosp | The Bronx | New York | 10465 | — |
| Montefiore Med Ctr / Bronx Municipal Hosp | 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 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 27710 | — |
| Bowman Gray School of Medicine / Wake Forest Univ | Winston-Salem | North Carolina | 27103 | — |
| Holmes Hosp / Univ of Cincinnati Med Ctr | Cincinnati | Ohio | 452670405 | — |
| Univ Hosp of Cleveland / Case Western Reserve Univ | Cleveland | Ohio | 44106 | — |
| Ohio State Univ Hosp Clinic | Columbus | Ohio | 432101228 | — |
| Med College of Ohio | Toledo | Ohio | 43699 | — |
| Milton S Hershey Med Ctr | Hershey | Pennsylvania | 170330850 | — |
| Univ of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Hemophilia Ctr of Western PA / Univ of Pittsburgh | Pittsburgh | Pennsylvania | 15219 | — |
| Univ of Pittsburgh Med School | Pittsburgh | Pennsylvania | — | — |
| Julio Arroyo | West Columbia | South Carolina | 29169 | — |
| Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr | Knoxville | Tennessee | 37920 | — |
| Hermann Hosp / Univ Texas Health Science Ctr | Houston | Texas | 77030 | — |
| Dr Stephen L Green | Hampton | Virginia | 23666 | — |
| Univ of Washington | Seattle | Washington | 98105 | — |
| Dr Brian Buggy | Milwaukee | Wisconsin | 53215 | — |
| Milwaukee County Med Complex | Milwaukee | Wisconsin | 53226 | — |
| Great Lakes Hemophilia Foundation | Milwaukee | Wisconsin | 53233 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000671, 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 Mar 13, 2011 · Synced Sep 11, 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 NCT00000671 live on ClinicalTrials.gov.