A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy
Public ClinicalTrials.gov record NCT00000651. 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 evaluate the safety of zalcitabine (dideoxycytidine; ddC) alone and in combination with zidovudine (AZT) versus AZT alone when administered to asymptomatic patients with a CD4 count = or \< 200 cells/mm3 and symptomatic patients with a CD4 count = or \< 300 cells/mm3. To compare the effectiveness of ddC alone and in combination with AZT versus AZT alone. ddC has been shown to demonstrate an antiviral effect. AZT has been shown to significantly decrease mortality and reduce the frequency of opportunistic infections in patients with AIDS or advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and patients progress with more opportunistic infections and higher mortality rates. Because of the demonstrated antiviral activity, absence of hematologic toxicity, and lack of cross tolerance in laboratory studies of ddC, a study to investigate the long-term effectiveness of ddC in patients with HIV infection who have received AZT therapy is warranted.
Study identification
- NCT ID
- NCT00000651
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 750 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 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
- May 1993 (Actual)
- Last update posted
- Nov 2, 2021
Ends 1993
United States locations
- U.S. sites
- 40
- U.S. states
- 16
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC CRS | Los Angeles | California | 90033 | — |
| UCLA CARE Center CRS | Los Angeles | California | 90095 | — |
| UCSD Maternal, Child, and Adolescent HIV CRS | San Diego | California | 92103 | — |
| Ucsd, Avrc Crs | San Diego | California | — | — |
| Ucsf Aids Crs | San Francisco | California | — | — |
| Harbor-UCLA Med. Ctr. CRS | Torrance | California | 90502 | — |
| University of Colorado Hospital CRS | Aurora | Colorado | — | — |
| Univ. of Miami AIDS CRS | Miami | Florida | 33136 | — |
| Northwestern University CRS | Chicago | Illinois | — | — |
| Rush Univ. Med. Ctr. ACTG CRS | Chicago | Illinois | — | — |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 46202 | — |
| Tulane Hemophilia Treatment Ctr. | New Orleans | Louisiana | — | — |
| Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU | New Orleans | Louisiana | — | — |
| Johns Hopkins Adult AIDS CRS | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital ACTG CRS | Boston | Massachusetts | 02114 | — |
| HMS - Children's Hosp. Boston, Div. of Infectious Diseases | Boston | Massachusetts | 02115 | — |
| Bmc Actg Crs | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess - East Campus A0102 CRS | Boston | Massachusetts | 02215 | — |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston | Massachusetts | 02215 | — |
| Brigham and Women's Hosp., Div. of Infectious Disease | Boston | Massachusetts | — | — |
| University of Minnesota, ACTU | Minneapolis | Minnesota | 55455 | — |
| St. Louis ConnectCare, Infectious Diseases Clinic | St Louis | Missouri | — | — |
| Washington U CRS | St Louis | Missouri | — | — |
| NJ Med. School CRS | Newark | New Jersey | 07103 | — |
| SUNY - Buffalo, Erie County Medical Ctr. | Buffalo | New York | 14215 | — |
| NYU Med. Ctr., Dept. of Medicine | New York | New York | 10016 | — |
| Cornell University A2201 | New York | New York | 10021 | — |
| Memorial Sloan-Kettering Cancer Ctr. | New York | New York | 10021 | — |
| Beth Israel Med. Ctr. (Mt. Sinai) | New York | New York | 10029 | — |
| NY Univ. HIV/AIDS CRS | New York | New York | — | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | — | — |
| Unc Aids Crs | Chapel Hill | North Carolina | 27599 | — |
| Carolinas HealthCare System, Carolinas Med. Ctr. | Charlotte | North Carolina | — | — |
| Duke Univ. Med. Ctr. Adult CRS | Durham | North Carolina | 27710 | — |
| Regional Center for Infectious Disease, Wendover Medical Center CRS | Greensboro | North Carolina | — | — |
| Univ. of Cincinnati CRS | Cincinnati | Ohio | 45267 | — |
| Case CRS | Cleveland | Ohio | 44106 | — |
| The Ohio State Univ. AIDS CRS | Columbus | Ohio | 43210 | — |
| Pitt CRS | Pittsburgh | Pennsylvania | 15213 | — |
| University of Washington AIDS CRS | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000651, 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 2, 2021 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000651 live on ClinicalTrials.gov.