Performance of the applied biosystems ViroSeq human immunodeficiency virus type 1 (HIV-1) genotyping system for sequence-based analysis of HIV-1 in pediatric plasma samples.
S Cunningham, B Ank, D Lewis...
https://pubmed.ncbi.nlm.nih.gov/11283037Completed
Phase 1
Age: 4Months - 17Years
All Genders
ID00001091
A Phase II Rolling Arm Master Protocol (PRAM) of Novel Antiretroviral Therapy in Stable Experienced HIV-Infected Children. PRAM-2: A Phase I/II Randomized, Multicenter Protocol Comparing Four Antiretroviral Regimens Containing Combinations of Protease Inhibitors, NRTIs and an NNRTI
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
200
Participants Needed
55
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 it is safe and effective to give HIV-infected children and teens 1 of 4 anti-HIV drug combinations. Decreasing HIV levels in infected patients can slow down disease progression. Further study is needed to find out which drug combinations are most effective in doing this.
CONDITIONS
Official Title
Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens
Who Can Participate
Age: 4Months - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have received the same continuous anti-HIV treatment for the past 16 weeks (missing no more than 6 weeks of treatment total during those 16 weeks).
- Are between 4 months and 17 years old (consent of parent or guardian required).
Exclusion Criteria
Patients will not be eligible if they:
- Have certain serious conditions such as cancer, an opportunistic (AIDS-related) infection, or other serious infection.
- Have ever taken any of the study drugs or any protease inhibitor.
- Are currently taking any anti-HIV drugs.
- Have taken an investigational drug within 14 days of entry into the study. (Co-enrollment in ACTG 219, ACTG 220 and certain ACTG opportunistic infection studies is allowed.)
- Are taking certain other drugs.
- Are pregnant.
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: 55 locations
1
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
Status Unknown
2
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Status Unknown
3
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
Status Unknown
4
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States, 900276016
Status Unknown
5
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Status Unknown
6
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Status Unknown
7
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
Status Unknown
8
Children's Hosp of Oakland
Oakland, California, United States, 946091809
Status Unknown
9
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
Status Unknown
10
Connecticut Children's Med Ctr - Pediatric
Hartford, Connecticut, United States, 06106
Status Unknown
11
Yale Univ Med School
New Haven, Connecticut, United States, 06504
Status Unknown
12
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States, 200102916
Status Unknown
13
Washington Hosp Ctr
Washington D.C., District of Columbia, United States, 200102931
Status Unknown
14
Howard Univ Hosp
Washington D.C., District of Columbia, United States, 20060
Status Unknown
15
North Broward Hosp District
Fort Lauderdale, Florida, United States, 33311
Status Unknown
16
Univ of Florida Gainesville
Gainesville, Florida, United States, 32610
Status Unknown
17
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
Status Unknown
18
Palm Beach County Health Dept
Riviera Beach, Florida, United States, 33404
Status Unknown
19
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States, 30306
Status Unknown
20
Med College of Georgia
Augusta, Georgia, United States, 30912
Status Unknown
21
Cook County Hosp
Chicago, Illinois, United States, 60612
Status Unknown
22
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States, 60612
Status Unknown
23
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Status Unknown
24
Univ of Chicago Children's Hosp
Chicago, Illinois, United States, 606371470
Status Unknown
25
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
Status Unknown
26
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
Status Unknown
27
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
Status Unknown
28
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Status Unknown
29
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
Status Unknown
30
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States, 39213
Status Unknown
31
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States, 089030019
Status Unknown
32
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 07103
Status Unknown
33
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, United States, 11203
Status Unknown
34
SUNY - Brooklyn
Brooklyn, New York, United States, 11203
Status Unknown
35
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Status Unknown
36
Schneider Children's Hosp
New Hyde Park, New York, United States, 11040
Status Unknown
37
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
38
Cornell Univ Med College
New York, New York, United States, 10021
Status Unknown
39
Metropolitan Hosp Ctr
New York, New York, United States, 10029
Status Unknown
40
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
41
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
42
Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
43
Univ of Rochester Med Ctr
Rochester, New York, United States, 146420001
Status Unknown
44
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
Status Unknown
45
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States, 10457
Status Unknown
46
Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr
The Bronx, New York, United States, 10461
Status Unknown
47
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States, 10461
Status Unknown
48
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 191044318
Status Unknown
49
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States, 191341095
Status Unknown
50
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
Status Unknown
51
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 372322581
Status Unknown
52
Children's Hosp of the King's Daughters
Norfolk, Virginia, United States, 23507
Status Unknown
53
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Status Unknown
54
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, Puerto Rico, 00956
Status Unknown
55
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Status Unknown
Loading map...
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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S H Eshleman, P Krogstad, J B Jackson...
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Paul Krogstad, Sophia Lee, George Johnson...
https://pubmed.ncbi.nlm.nih.gov/11880966Reported adherence as a determinant of response to highly active antiretroviral therapy in children who have human immunodeficiency virus infection.
Russell B Van Dyke, Sophia Lee, George M Johnson...
https://pubmed.ncbi.nlm.nih.gov/11927734Combination nucleoside analog reverse transcriptase inhibitor(s) plus nevirapine, nelfinavir, or ritonavir in stable antiretroviral therapy-experienced HIV-infected children: week 24 results of a randomized controlled trial--PACTG 377. Pediatric AIDS Clinical Trials Group 377 Study Team.
A Wiznia, K Stanley, P Krogstad...
https://pubmed.ncbi.nlm.nih.gov/10954886Neuropsychological functioning and viral load in stable antiretroviral therapy-experienced HIV-infected children.
Rita J Jeremy, Soyeon Kim, Molly Nozyce...
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Howard M Rosenblatt, Lin Y Song, Sharon A Nachman...
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Akihiko Saitoh, Elizabeth Sarles, Edmund Capparelli...
https://pubmed.ncbi.nlm.nih.gov/18090046