The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients
Public ClinicalTrials.gov record NCT00001074. 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 Phase I/II Dosing Study of the Safety and Antiretroviral Activity of Hydroxyurea Alone and in Combination With ddI Compared With ddI Alone in Subjects With HIV Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To determine the safety and tolerability of hydroxyurea at two doses alone and in combination with didanosine (ddI). To compare the short term antiviral effect of ddI monotherapy versus hydroxyurea plus ddI, as measured by plasma RNA levels at 8 weeks of therapy. \[AS PER AMENDMENT 10/1/97: Accrual to arms involving hydroxyurea alone has been closed.\] Current antiviral therapies for HIV-1 are limited by a few choices, and the lack of sustained clinical benefit from the drugs. The mechanisms that account for the lack of prolonged inhibition of viral replication by these agents are not fully understood. The activity of RT inhibitors might be potentiated by inhibiting host cellular enzymes essential for efficient HIV reverse transcription. Based on this information, comparisons of the antiviral effects of ddI monotherapy and hydroxyurea plus ddI, with the cellular enzyme ribonucleotide reductase as a potential target, should be done.
Study identification
- NCT ID
- NCT00001074
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 140 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
- Dec 31, 1999
- Last update posted
- Oct 31, 2021
Ends 2000
United States locations
- U.S. sites
- 18
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of California / San Diego Treatment Ctr | San Diego | California | 921036325 | — |
| Stanford at Kaiser / Kaiser Permanente Med Ctr | San Francisco | California | 94115 | — |
| Stanford Univ Med Ctr | Stanford | California | 943055107 | — |
| Harbor UCLA Med Ctr | Torrance | California | 90502 | — |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | — |
| Johns Hopkins Hosp | Baltimore | Maryland | 21287 | — |
| Beth Israel Med Ctr | New York | New York | 10003 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Mount Sinai Med Ctr | New York | New York | 10029 | — |
| Univ of North Carolina | Chapel Hill | North Carolina | 275997215 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 27710 | — |
| Univ of Cincinnati | Cincinnati | Ohio | 452670405 | — |
| Case Western Reserve Univ | Cleveland | Ohio | 44106 | — |
| MetroHealth Med Ctr | Cleveland | Ohio | 441091998 | — |
| Univ of Pennsylvania at Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson Univ Hosp | Philadelphia | Pennsylvania | 191075098 | — |
| Julio Arroyo | West Columbia | South Carolina | 29169 | — |
| Univ of Washington | Seattle | Washington | 981224304 | — |
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 NCT00001074, 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 Oct 31, 2021 · Synced Sep 2, 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 NCT00001074 live on ClinicalTrials.gov.