A Comparison of Zidovudine (AZT) Used Alone or in Combination With Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients
Public ClinicalTrials.gov record NCT00001022. 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, Comparative Trial of Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus Dideoxycytidine (ddC) in HIV-Infected Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary: To compare the efficacy of zidovudine ( AZT ) given alone versus AZT plus didanosine ( ddI ) versus AZT plus zalcitabine ( dideoxycytidine; ddC ) in delaying the occurrence of AIDS-related conditions in HIV-infected patients. Secondary: To compare the frequency and severity of adverse experiences in the three regimens. To compare the mortality rates in the three regimens. To compare the effects of antiretroviral regimens on CD4+ cell levels. Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity, primarily myelosuppression, and by the emergence of drug-resistant HIV strains. It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of development of drug-resistant strains, than AZT alone.
Study identification
- NCT ID
- NCT00001022
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,200 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
- Dec 1995 (Actual)
- Last update posted
- Nov 4, 2021
Ends 1995
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Community Consortium of San Francisco | San Francisco | California | 94110 | — |
| Denver CPCRA / Denver Public Hlth | Denver | Colorado | 80204 | — |
| Hill Health Corp | New Haven | Connecticut | 06519 | — |
| Wilmington Hosp / Med Ctr of Delaware | Wilmington | Delaware | 19899 | — |
| Veterans Administration Med Ctr / Regional AIDS Program | Washington D.C. | District of Columbia | 20422 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | — |
| AIDS Research Alliance - Chicago | Chicago | Illinois | 60657 | — |
| Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | New Orleans | Louisiana | 70112 | — |
| Comprehensive AIDS Alliance of Detroit | Detroit | Michigan | 48201 | — |
| Henry Ford Hosp | Detroit | Michigan | 48202 | — |
| North Jersey Community Research Initiative | Newark | New Jersey | 07103 | — |
| Addiction Research and Treatment Corp | Brooklyn | New York | 11201 | — |
| Clinical Directors Network of Region II | New York | New York | 10011 | — |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | New York | New York | 10037 | — |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | Portland | Oregon | 97210 | — |
| Richmond AIDS Consortium | Richmond | Virginia | 23298 | — |
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 NCT00001022, 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
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00001022 live on ClinicalTrials.gov.