The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used With and Without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs
Public ClinicalTrials.gov record NCT00002391. 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 Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of 1592U89/Zidovudine (ZDV)/Lamivudine (3TC) Versus the Combination of Zidovudine (ZDV)/Lamivudine (3TC) in HIV-1 Therapy-Experienced Pediatric Patients.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To compare the safety, tolerance, durability of the viral load response and the antiviral activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen. To determine the clinical efficacy of the two regimens as measured survival, disease progression, weight growth velocity, and neuropsychological or neurological changes. To assess the development of viral resistance and relative pharmacokinetics associated with each regimen.
Study identification
- NCT ID
- NCT00002391
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Months to 12 Years
- 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
- Not listed
- Last update posted
- Jun 24, 2005
United States locations
- U.S. sites
- 30
- U.S. states
- 13
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station | Birmingham | Alabama | 35294 | — |
| Children's Hosp Los Angeles | Los Angeles | California | 90027 | — |
| Los Angeles County - USC Med Ctr | Los Angeles | California | 90033 | — |
| Children's Diagnostic Treatment Ctr | Fort Lauderdale | Florida | 33301 | — |
| Univ of Florida - Gainesville / Infectious Dis & Immun | Gainesville | Florida | 326100296 | — |
| Univ of Miami / Fox Cancer Research Ctr | Miami | Florida | 33136 | — |
| Arnold Palmer Hosp for Women and Children | Orlando | Florida | 32806 | — |
| Pediatric Special Immunology Clinic / HRS / PBC PHU | Riviera Beach | Florida | 33404 | — |
| Univ of South Florida All Children's Hosp | St. Petersburg | Florida | 33701 | — |
| Dr Patricia Emmanuel | Tampa | Florida | 33606 | — |
| Mt Sinai Hosp Med Ctr / Dept of Pediatrics | Chicago | Illinois | 60608 | — |
| Tulane Univ Med School | New Orleans | Louisiana | 70112 | — |
| Univ of Minnesota Med School | Minneapolis | Minnesota | 55455 | — |
| UMDNJ / Division of Allergy Immunology & Infectious Diseases | Newark | New Jersey | 07103 | — |
| PACT Program | Buffalo | New York | 14222 | — |
| North Shore Univ Hosp / Pediatric Immunology | Great Neck | New York | 11021 | — |
| Schneider Children's Hosp | New Hyde Park | New York | 11040 | — |
| New York Hosp - Cornell / Program for Children with AIDS | New York | New York | 10021 | — |
| St Luke's - Roosevelt Hosp Ctr | New York | New York | 10025 | — |
| SUNY Health Ctr at Stony Brook / Pediatric Infectious Dis | Stony Brook | New York | 117948111 | — |
| SUNY Health Sciences Ctr at Syracuse / Dept of Pediatrics | Syracuse | New York | 13210 | — |
| Bronx Lebanon Hosp Ctr / Dept of Pediatrics | The Bronx | New York | 10457 | — |
| Univ of North Carolina / Pediatric Infectious Diseases | Chapel Hill | North Carolina | 27514 | — |
| Duke Univ Med Ctr / Pediatrics Dept / Infec Dis | Durham | North Carolina | 27710 | — |
| The Children's Med Ctr / Division of Infectious Dis | Dayton | Ohio | 454041815 | — |
| Med Univ of South Carolina | Charleston | South Carolina | 294253312 | — |
| Children's Med Ctr of Dallas / ARMS Clinic | Dallas | Texas | 75235 | — |
| Cook's Ft Worth Children Med Ctr / Pediatric Inf Dis | Fort Worth | Texas | 76104 | — |
| Univ of Texas Health Sciences Ctr | San Antonio | Texas | 78284 | — |
| Eastern VA Med Sch / Children's Hosp of the King's Daughters | Norfolk | Virginia | 23507 | — |
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 NCT00002391, 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 Jun 24, 2005 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00002391 live on ClinicalTrials.gov.