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NCT00000653 · ClinicalTrials.gov registry record · Phase 2
A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT
A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 20
- Study locations
NCT00000653 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 140 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT00000653, 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
- 140 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity during prolonged AZT therapy), demonstrated disease progression after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months of AZT therapy. As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.
Conditions Studied
Interventions
- DRUG Zalcitabine
Study Locations (20)
California
- 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
Massachusetts
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases - Boston
- BMC, Div. of Ped Infectious Diseases - Boston
- Baystate Health, Baystate Med. Ctr. - Springfield
- WNE Maternal Pediatric Adolescent AIDS CRS - Worcester
Illinois
- Cook County Hosp. - Chicago
- Univ. of Illinois College of Medicine at Chicago, Dept. of Peds. - Chicago
- Chicago Children's CRS - Chicago
Louisiana
- Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU - New Orleans
- Tulane/LSU Maternal/Child CRS - New Orleans
Maryland
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology - Baltimore
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases - Baltimore
District of Columbia
- Children's National Med. Ctr., ACTU - Washington D.C.
Florida
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS - Miami
Georgia
- Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Est. Completion | 1995-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000653
The ClinicalTrials.gov registry entry for NCT00000653 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 140 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 (69% 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 Zalcitabine is the first listed.
NCT00000653 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Massachusetts, Illinois.
Frequently Asked Questions
What is clinical trial NCT00000653 about?
NCT00000653 is a clinical study titled "A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT". To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity du...
What is the current status of trial NCT00000653?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. Estimated completion is 1995-06.
What conditions does trial NCT00000653 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00000653?
The interventions under investigation include: Zalcitabine (DRUG).
Who is sponsoring clinical trial NCT00000653?
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 NCT00000653 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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