A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients Between Ages 4 and 22 With 7 Drugs, Some at Higher Than Usual Doses
Public ClinicalTrials.gov record NCT00001108. 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
Multi-Drug Antiretroviral Therapy for Heavily Pretreated Pediatric AIDS Patients: A Phase I Proof of Concept Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to see if 7 drugs, some of them given at higher doses than normal, are safe and tolerated by young patients with AIDS who have failed to respond to other treatments. The study will also see what effect taking several anti-HIV drugs together at high doses has on the body's ability to fight HIV infection. The 7 drugs that will be given in this study are stavudine (d4T), didanosine (ddI), lamivudine (3TC), nelfinavir (NFV), ritonavir (RTV), saquinavir (SQV), and nevirapine (NVP). (This study has been changed from an 8-drug regimen to a 7-drug regimen. Patients no longer receive the drug hydroxyurea \[HU\].) Doctors are seeing many HIV-positive children who did not get good long-term results from the current anti-HIV drugs. Some doctors believe anti-HIV drugs fail because drug levels in the body are too low. In this study, doctors will give patients 7 drugs, some at higher doses than normal. Since it is very important that patients on the study take all of these drugs, doctors will make it as easy as possible. Doctors want to try this because children with advanced AIDS have few treatment choices.
Study identification
- NCT ID
- NCT00001108
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 6 participants
Conditions and interventions
Conditions
Interventions
- Ritonavir Drug
- Nelfinavir mesylate Drug
- Saquinavir Drug
- Nevirapine Drug
- Lamivudine Drug
- Stavudine Drug
- Didanosine Drug
Drug
Eligibility (public fields only)
- Age range
- 4 Years to 22 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
- May 31, 2000
- Last update posted
- Oct 31, 2021
Ends 2000
United States locations
- U.S. sites
- 19
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama at Birmingham - Pediatric | Birmingham | Alabama | 35233 | — |
| UCLA Med Ctr / Pediatric | Los Angeles | California | 900951752 | — |
| Univ of Miami (Pediatric) | Miami | Florida | 33161 | — |
| Sacred Heart Children's Hosp / CMS of Florida | Pensacola | Florida | 32503 | — |
| Cook County Hosp | Chicago | Illinois | 60612 | — |
| Chicago Children's Memorial Hosp | Chicago | Illinois | 606143394 | — |
| Tulane Univ / Charity Hosp of New Orleans | New Orleans | Louisiana | 701122699 | — |
| Johns Hopkins Hosp - Pediatric | Baltimore | Maryland | 212874933 | — |
| Children's Hosp of Boston | Boston | Massachusetts | 021155724 | — |
| Univ of Massachusetts Med School | Worcester | Massachusetts | 016550001 | — |
| Univ of Mississippi Med Ctr | Jackson | Mississippi | 39213 | — |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | Newark | New Jersey | 071032714 | — |
| North Shore Univ Hosp | Great Neck | New York | 11021 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Columbia Presbyterian Med Ctr | New York | New York | 10032 | — |
| Incarnation Children's Ctr / Columbia Presbyterian Med Ctr | New York | New York | 10032 | — |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | Syracuse | New York | 13210 | — |
| Saint Jude Children's Research Hosp of Memphis | Memphis | Tennessee | 381052794 | — |
| Med College of Virginia | Richmond | Virginia | 23219 | — |
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 NCT00001108, 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 31, 2021 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00001108 live on ClinicalTrials.gov.