A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children
Public ClinicalTrials.gov record NCT00001066. 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 Randomized Comparative Study of Combined Zidovudine-Lamivudine (3TC) vs. the Better of ddI Monotherapy vs. Zidovudine Plus Ddl in Symptomatic HIV-1 Infected Children
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected children who received less than 56 days of prior antiretroviral therapy. To evaluate the safety and tolerance of 3TC/AZT in this patient population. To determine other measures of diseases in response to the study regimens. Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.
Study identification
- NCT ID
- NCT00001066
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 740 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Months to 15 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
- Jan 2001 (Actual)
- Completion
- Not listed
- Last update posted
- Mar 2, 2011
United States locations
- U.S. sites
- 87
- U.S. states
- 27
- U.S. cities
- 64
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama at Birmingham Schl of Med / Pediatrics | Birmingham | Alabama | 35294 | — |
| Arkansas Children's Hosp | Little Rock | Arkansas | 72202 | — |
| UCSD Med Ctr / Pediatrics / Clinical Sciences | La Jolla | California | 920930672 | — |
| Long Beach Memorial (Pediatric) | Long Beach | California | 90801 | — |
| Children's Hosp of Los Angeles/UCLA Med Ctr | Los Angeles | California | 900276016 | — |
| Los Angeles County - USC Med Ctr | Los Angeles | California | 90033 | — |
| UCLA Med Ctr / Pediatric | Los Angeles | California | 900951752 | — |
| Harbor - UCLA Med Ctr / UCLA School of Medicine | Los Angeles | California | 905022004 | — |
| Children's Hosp of Oakland | Oakland | California | 946091809 | — |
| Univ of California / Davis | Sacramento | California | 958172208 | — |
| UCSF / Moffitt Hosp - Pediatric | San Francisco | California | 941430105 | — |
| Stanford Univ School of Medicine | Stanford | California | 943054149 | — |
| Children's Hosp of Denver | Denver | Colorado | 802181088 | — |
| Univ of Connecticut / Farmington | Farmington | Connecticut | 06032 | — |
| Yale Univ Med School | New Haven | Connecticut | 06504 | — |
| Children's Hosp of Washington DC | Washington D.C. | District of Columbia | 200102916 | — |
| Howard Univ Hosp | Washington D.C. | District of Columbia | 20060 | — |
| Children's Diagnostic and Treatment Ctr of South Florida | Fort Lauderdale | Florida | 33301 | — |
| Univ of Florida | Gainesville | Florida | 32610 | — |
| Univ of Florida Health Science Ctr / Pediatrics | Jacksonville | Florida | 32209 | — |
| Univ of Miami (Pediatric) | Miami | Florida | 33161 | — |
| Arnold Palmer Hosp for Children & Women | Orlando | Florida | 32806 | — |
| All Children's Hosp | St. Petersburg | Florida | 33701 | — |
| Univ of South Florida | Tampa | Florida | 33606 | — |
| Saint Joseph's Hosp | Tampa | Florida | 33614 | — |
| HRS Palm Beach County Public Health Unit | West Palm Beach | Florida | 33407 | — |
| Emory Univ Hosp / Pediatrics | Atlanta | Georgia | 30306 | — |
| Med College of Georgia | Augusta | Georgia | 30912 | — |
| Mem Children's Hosp | Savannah | Georgia | 31404 | — |
| Mount Sinai Hosp Med Ctr | Chicago | Illinois | 60608 | — |
| 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 | — |
| Johns Hopkins Hosp - Pediatric | Baltimore | Maryland | 212874933 | — |
| Children's Hosp of Boston | Boston | Massachusetts | 021155724 | — |
| Boston City Hosp / Pediatrics | Boston | Massachusetts | 02118 | — |
| 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 Minnesota Med School | Minneapolis | Minnesota | 55455 | — |
| Univ of Mississippi Med Ctr | Jackson | Mississippi | 392165405 | — |
| St Louis Children's Hosp | St Louis | Missouri | 63110 | — |
| UMDNJ - Robert Wood Johnson Med School / Pediatrics | New Brunswick | New Jersey | 089030019 | — |
| 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 | — |
| King's County Hosp Ctr / Pediatrics | Brooklyn | New York | 11203 | — |
| SUNY - Brooklyn | Brooklyn | New York | 11203 | — |
| Children's Hosp of Buffalo | Buffalo | New York | 14222 | — |
| North Shore Univ Hosp | Great Neck | New York | 11021 | — |
| Schneider Children's Hosp | New Hyde Park | New York | 11040 | — |
| Beth Israel Med Ctr / Pediatrics | New York | New York | 10003 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Saint Luke's - Roosevelt Hosp Ctr | New York | New York | 10025 | — |
| 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 | — |
| Harlem Hosp Ctr | New York | New York | 10037 | — |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | — |
| State Univ of New York at Stony Brook | Stony Brook | New York | 117948111 | — |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | Syracuse | New York | 13210 | — |
| Bronx Lebanon Hosp Ctr | The Bronx | New York | 10457 | — |
| Westchester Hosp | Valhalla | New York | 10595 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 277103499 | — |
| Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Hosp / Univ Hosp | Cincinnati | Ohio | 452292899 | — |
| Case Western Reserve Univ - Pediatric | Cleveland | Ohio | 44106 | — |
| Columbus Children's Hosp | Columbus | Ohio | 432052696 | — |
| Children's Med Ctr | Dayton | Ohio | 454041518 | — |
| Children's Hosp of Philadelphia | Philadelphia | Pennsylvania | 191044318 | — |
| Saint Christopher's Hosp for Children | Philadelphia | Pennsylvania | 191341095 | — |
| Rhode Island Hosp / Brown Univ | Providence | Rhode Island | 02903 | — |
| Med Univ of South Carolina | Charleston | South Carolina | 294253312 | — |
| Univ of South Carolina School of Med | Columbia | South Carolina | 29203 | — |
| Saint Jude Children's Research Hosp of Memphis | Memphis | Tennessee | 381052794 | — |
| Children's Med Ctr of Dallas | Dallas | Texas | 75235 | — |
| Cook - Fort Worth Children's Med Ctr | Fort Worth | Texas | 76104 | — |
| Hermann Hosp / Univ Texas Health Science Ctr | Houston | Texas | 77030 | — |
| Texas Children's Hosp / Baylor Univ | Houston | Texas | 77030 | — |
| Univ of Texas Health Science Ctr | San Antonio | Texas | 78240 | — |
| Senetara Norfolk Gen Hosp | Norfolk | Virginia | 23507 | — |
| Virginia Commonwealth Univ | Richmond | Virginia | 232980413 | — |
| Children's Hospital & Medical Center / Seattle ACTU | Seattle | Washington | 981050371 | — |
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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00001066, 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 Mar 2, 2011 · Synced Oct 27, 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 NCT00001066 live on ClinicalTrials.gov.