Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00001049 · ClinicalTrials.gov registry record · Phase 1
A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT00001049 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 180 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT00001049, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Didanosine
Study Locations (20)
California
- UCSD Med Ctr / Pediatrics / Clinical Sciences - La Jolla
- Long Beach Memorial (Pediatric) - Long Beach
- Los Angeles County - USC Med Ctr - Los Angeles
- Harbor - UCLA Med Ctr / UCLA School of Medicine - Los Angeles
- Children's Hosp of Oakland - Oakland
- San Francisco Gen Hosp - San Francisco
- UCSF / Moffitt Hosp - Pediatric - San Francisco
Florida
- North Broward Hosp District - Fort Lauderdale
- Univ of Florida Health Science Ctr / Pediatrics - Jacksonville
- Univ of Miami (Pediatric) - Miami
- Palm Beach County Health Dept - Riviera Beach
Illinois
- Cook County Hosp - Chicago
- Univ of Illinois College of Medicine / Pediatrics - Chicago
- Chicago Children's Memorial Hosp - Chicago
- Univ of Chicago Children's Hosp - Chicago
District of Columbia
- Children's Hosp of Washington DC - Washington D.C.
- Howard Univ Hosp - Washington D.C.
Alabama
- Univ of Alabama at Birmingham Schl of Med / Pediatrics - Birmingham
Colorado
- Children's Hosp of Denver - Denver
Connecticut
- Univ of Connecticut / Farmington - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Est. Completion | 1998-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001049
The ClinicalTrials.gov registry entry for NCT00001049 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (60% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Zidovudine is the first listed.
NCT00001049 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00001049 about?
NCT00001049 is a clinical study titled "A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV". 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...
What is the current status of trial NCT00001049?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 180 participants. Estimated completion is 1998-06.
What conditions does trial NCT00001049 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00001049?
The interventions under investigation include: Zidovudine (DRUG), Didanosine (DRUG).
Who is sponsoring clinical trial NCT00001049?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001049 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
CAR-T Cells for HIV Infection
RECRUITING · Phase 1
-
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
RECRUITING · Phase 1
-
Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706
RECRUITING · Phase 1
-
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
RECRUITING · Phase 1
-
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
RECRUITING · Phase 1
-
First Time in Human Study of Long Acting VH4524184 Formulations
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.