Completed
Multi-Drug Antiretroviral Therapy for Heavily Pretreated Pediatric AIDS Patients: A Phase I Proof of Concept Trial
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-01
6
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Patients may be eligible for this trial if they:
- Are HIV-positive.
- Have HIV levels of 10,000 copies/ml or more.
- Are between ages 4 and 22.
- Have motivation and ability to conform to the complex treatment regimen.
- Agree to practice abstinence or use 2 effective methods of birth control during the study and until 3 months after stopping the study drugs, if sexually active.
- Have written informed consent from a parent or legal guardian if under age 18.
- Have used at least 3 different nucleoside reverse transcriptase inhibitors (NRTIs) for at least 3 months each or have shown resistance to at least 3 different NRTIs.
- Have used at least 1 nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 3 months each or have shown resistance.
- Have used at least 2 different courses of a protease inhibitor (PI)-containing regimen, each of which was at least 6 months, or have evidence of mutations to at least 2 different PIs.
- This study has been changed. The inclusion criteria reflects a change in the prior anti-HIV therapy required, age requirement, and the required CD4 and HIV levels.
Exclusion Criteria
Patients will not be eligible for this trial if they:
- Are allergic to even 1 study drug or have ever had to stop 1 of these drugs because of a bad reaction to it.
- Have a history of diabetes, hepatitis C, hepatitis B, or certain diseases of the nervous system, heart, or pancreas.
- Have had a serious infection within 14 days of starting the study.
- Need certain drugs that interact with the study drugs. (See Technical Summary for more details.)
- Are pregnant or breast-feeding.
- Have had hepatitis within 30 days of study entry.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 19 locations
1
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
Status Unknown
2
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Status Unknown
3
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Status Unknown
4
Sacred Heart Children's Hosp / CMS of Florida
Pensacola, Florida, United States, 32503
Status Unknown
5
Cook County Hosp
Chicago, Illinois, United States, 60612
Status Unknown
6
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Status Unknown
7
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
Status Unknown
8
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
Status Unknown
9
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Status Unknown
10
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
Status Unknown
11
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States, 39213
Status Unknown
12
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Status Unknown
13
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Status Unknown
14
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
15
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
16
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
17
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
Status Unknown
18
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States, 381052794
Status Unknown
19
Med College of Virginia
Richmond, Virginia, United States, 23219
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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