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NCT00000963 · ClinicalTrials.gov registry record · Phase 2
A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine
A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT00000963 is a Phase 2 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 300 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT00000963, a Phase 2 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine (AZT) because of intolerance and/or who have experienced progressive disease while on AZT. The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.
Conditions Studied
Interventions
- DRUG Didanosine
Study Locations (20)
California
- Long Beach Memorial Med. Ctr., Miller Children's Hosp. - Long Beach
- Usc La Nichd Crs - Los Angeles
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS - Los Angeles
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. - Oakland
- UCSD Maternal, Child, and Adolescent HIV CRS - San Diego
- UCSF Pediatric AIDS CRS - San Francisco
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases - Torrance
Illinois
- Cook County Hosp. - Chicago
- Univ. of Illinois College of Medicine at Chicago, Dept. of Peds. - Chicago
- Chicago Children's CRS - Chicago
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease - Chicago
Connecticut
- Univ. of Connecticut Health Ctr., Dept. of Ped. - Farmington
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease - New Haven
District of Columbia
- Children's National Med. Ctr., ACTU - Washington D.C.
- Howard Univ. Washington DC NICHD CRS - Washington D.C.
Louisiana
- Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU - New Orleans
- Tulane/LSU Maternal/Child CRS - New Orleans
Florida
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS - Miami
Georgia
- Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases - Atlanta
Maryland
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Est. Completion | 1995-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000963
The ClinicalTrials.gov registry entry for NCT00000963 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (33% 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 1 intervention - of which Didanosine is the first listed.
NCT00000963 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Illinois, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00000963 about?
NCT00000963 is a clinical study titled "A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine". To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine (AZT) because of intolerance and/or who have experienced progressive disease while on AZT. The progression of immuno...
What is the current status of trial NCT00000963?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. Estimated completion is 1995-09.
What conditions does trial NCT00000963 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00000963?
The interventions under investigation include: Didanosine (DRUG).
Who is sponsoring clinical trial NCT00000963?
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 NCT00000963 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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