Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children
Public ClinicalTrials.gov record NCT00000893. 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 Phase I/II, Open-Label, AUC-Controlled Study to Determine the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in Children
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of EFZ to use in combination with NFV. Cohort II: The purpose of this study is to see how safe it is to give EFZ syrup combined with NFV and to measure the levels of EFZ and NFV in the blood. (This purpose reflects a change from the original since there are now 2 different cohorts of patients.) EFZ is an effective anti-HIV medication that easily can be combined with other drugs to treat HIV. This is an early study to determine a safe and effective dose for HIV-positive children. This study also will examine the correct dose of NFV to use in combination with EFZ.
Study identification
- NCT ID
- NCT00000893
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 103 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Months to 16 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
- Oct 1997 (Type not available)
- Primary completion
- Not listed
- Completion
- Dec 2002 (Actual)
- Last update posted
- Oct 29, 2021
1997 – 2002
United States locations
- U.S. sites
- 25
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Long Beach Memorial Med. Ctr., Miller Children's Hosp. | Long Beach | California | 90801 | — |
| UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | Los Angeles | California | — | — |
| Usc La Nichd Crs | Los Angeles | California | — | — |
| Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. | Oakland | California | — | — |
| UCSD Maternal, Child, and Adolescent HIV CRS | San Diego | California | — | — |
| Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases | Torrance | California | — | — |
| Howard Univ. Washington DC NICHD CRS | Washington D.C. | District of Columbia | 20060 | — |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida | 32209 | — |
| Tulane/LSU Maternal/Child CRS | New Orleans | Louisiana | 70112 | — |
| Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology | Baltimore | Maryland | 21201 | — |
| HMS - Children's Hosp. Boston, Div. of Infectious Diseases | Boston | Massachusetts | 021155724 | — |
| WNE Maternal Pediatric Adolescent AIDS CRS | Worcester | Massachusetts | 016550001 | — |
| Univ. of Mississippi Med. Ctr Children's Hosp. | Jackson | Mississippi | 39213 | — |
| SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS | Brooklyn | New York | 11203 | — |
| Metropolitan Hosp. Ctr. | New York | New York | 10029 | — |
| Harlem Hosp. Ctr. NY NICHD CRS | New York | New York | 10037 | — |
| NYU Med. Ctr., Dept. of Medicine | New York | New York | — | — |
| Nyu Ny Nichd Crs | New York | New York | — | — |
| Bronx-Lebanon Hosp. IMPAACT CRS | The Bronx | New York | 10457 | — |
| The Children's Hosp. of Philadelphia IMPAACT CRS | Philadelphia | Pennsylvania | 191044318 | — |
| St. Christopher's Hosp. for Children | Philadelphia | Pennsylvania | — | — |
| St. Jude/UTHSC CRS | Memphis | Tennessee | — | — |
| Texas Children's Hosp. CRS | Houston | Texas | — | — |
| Seattle Children's Hospital CRS | Seattle | Washington | — | — |
| UW School of Medicine - CHRMC | Seattle | Washington | — | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000893, 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 Oct 29, 2021 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000893 live on ClinicalTrials.gov.