A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV
Public ClinicalTrials.gov record NCT00001049. 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 Evaluation of the Safety and Toxicity of Zidovudine and Didanosine in Combination in HIV-Infected or Exposed Infants and a Phase II Study of the Effect of Didanosine vs. Combination Therapy With Zidovudine and Didanosine on HIV-1 RNA in Infants With HIV Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To determine the pharmacokinetics, safety, and efficacy of didanosine (ddI) alone or in combination with zidovudine (AZT) in HIV-infected infants. PER AMENDMENT 4/8/97: Part A study objectives are completed. Part B objectives: To assess the safety, toxicity, and tolerability and to compare anti-HIV activity, as measured by change in log10 RNA, of the two study arms. Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and rapid decline of CD4 count and immunologic function. Combination therapy may be preferred over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is little information on ddI monotherapy in young infants less than 90 days and no information on the use of combination therapy in this population.
Study identification
- NCT ID
- NCT00001049
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Day to 3 Months
- 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 1998 (Actual)
- Last update posted
- Nov 1, 2021
Ends 1998
United States locations
- U.S. sites
- 45
- U.S. states
- 17
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama at Birmingham Schl of Med / Pediatrics | Birmingham | Alabama | 35294 | — |
| UCSD Med Ctr / Pediatrics / Clinical Sciences | La Jolla | California | 920930672 | — |
| Long Beach Memorial (Pediatric) | Long Beach | California | 90801 | — |
| Los Angeles County - USC Med Ctr | Los Angeles | California | 90033 | — |
| Harbor - UCLA Med Ctr / UCLA School of Medicine | Los Angeles | California | 905022004 | — |
| Children's Hosp of Oakland | Oakland | California | 946091809 | — |
| San Francisco Gen Hosp | San Francisco | California | 94110 | — |
| UCSF / Moffitt Hosp - Pediatric | San Francisco | California | 941430105 | — |
| Children's Hosp of Denver | Denver | Colorado | 802181088 | — |
| Univ of Connecticut / Farmington | Farmington | Connecticut | 06032 | — |
| Children's Hosp of Washington DC | Washington D.C. | District of Columbia | 200102916 | — |
| Howard Univ Hosp | Washington D.C. | District of Columbia | 20060 | — |
| North Broward Hosp District | Fort Lauderdale | Florida | 33311 | — |
| Univ of Florida Health Science Ctr / Pediatrics | Jacksonville | Florida | 32209 | — |
| Univ of Miami (Pediatric) | Miami | Florida | 33161 | — |
| Palm Beach County Health Dept | Riviera Beach | Florida | 33404 | — |
| Cook County Hosp | Chicago | Illinois | 60612 | — |
| Univ of Illinois College of Medicine / Pediatrics | Chicago | Illinois | 60612 | — |
| Chicago Children's Memorial Hosp | Chicago | Illinois | 606143394 | — |
| Univ of Chicago Children's Hosp | Chicago | Illinois | 606371470 | — |
| Tulane Univ / Charity Hosp of New Orleans | New Orleans | Louisiana | 701122699 | — |
| Univ of Maryland at Baltimore / Univ Med Ctr | Baltimore | Maryland | 21201 | — |
| Children's Hosp of Boston | Boston | Massachusetts | 021155724 | — |
| Baystate Med Ctr of Springfield | Springfield | Massachusetts | 01199 | — |
| Univ of Massachusetts Med School | Worcester | Massachusetts | 016550001 | — |
| Children's Hosp of Michigan | Detroit | Michigan | 48201 | — |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | Newark | New Jersey | 071032714 | — |
| Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl | Newark | New Jersey | 07103 | — |
| Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | Newark | New Jersey | 071072198 | — |
| Children's Hosp at Albany Med Ctr | Albany | New York | 12208 | — |
| Schneider Children's Hosp | New Hyde Park | New York | 11040 | — |
| Metropolitan Hosp Ctr | New York | New York | 10029 | — |
| Mount Sinai Med Ctr / Pediatrics | New York | New York | 10029 | — |
| Columbia Presbyterian Med Ctr | New York | New York | 10032 | — |
| Incarnation Children's Ctr / Columbia Presbyterian Med Ctr | New York | New York | 10032 | — |
| Harlem Hosp Ctr | New York | New York | 10037 | — |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | — |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | Syracuse | New York | 13210 | — |
| Bronx Lebanon Hosp Ctr | The Bronx | New York | 10457 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 277103499 | — |
| Children's Hosp of Philadelphia | Philadelphia | Pennsylvania | 191044318 | — |
| Saint Christopher's Hosp for Children | Philadelphia | Pennsylvania | 191341095 | — |
| Med Univ of South Carolina | Charleston | South Carolina | 294253312 | — |
| Children's Hosp of the King's Daughters | Norfolk | Virginia | 23507 | — |
| Med College of Virginia | Richmond | Virginia | 23219 | — |
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 NCT00001049, 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 1, 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 NCT00001049 live on ClinicalTrials.gov.