Completed
A Randomized Trial of Two Saquinavir-Containing Combination Treatment Regimens in Children With HIV Infection
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
50
Participants Needed
36
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with other anti-HIV drugs. SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule form may be safer and more effective than other protease inhibitors.
CONDITIONS
Official Title
A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Your child may be eligible for this study if he or she:
- Is HIV-positive.
- Is 3 to 16 years of age (consent of parent or guardian is required).
- Has an HIV level greater than 10,000 copies/ml.
- Has never taken at least one of the following anti-HIV drugs: lamivudine, zidovudine, stavudine, or didanosine.
- Is able to swallow capsules and tablets.
Exclusion Criteria
Your child will not be eligible if he or she:
- Has cancer requiring chemotherapy.
- Has an acute opportunistic (AIDS-related) infection requiring therapy.
- Has had two or more episodes of moderate or severe diarrhea or vomiting in the 3 months prior to study entry.
- Has ever taken SQV or NFV.
- Is pregnant or breast-feeding.
- Is taking certain medications, including those that would interfere with the study drugs.
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: 36 locations
1
Univ of Alabama at Birmingham / Childrens Hosp of AL
Birmingham, Alabama, United States, 352330011
Status Unknown
2
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
Status Unknown
3
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
Status Unknown
4
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Status Unknown
5
Children's Hosp of Oakland
Oakland, California, United States, 946091809
Status Unknown
6
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
Status Unknown
7
Yale Univ Med School
New Haven, Connecticut, United States, 06504
Status Unknown
8
Howard Univ Hosp
Washington D.C., District of Columbia, United States, 20060
Status Unknown
9
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Status Unknown
10
Palm Beach County Health Dept
Riviera Beach, Florida, United States, 33404
Status Unknown
11
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States, 30306
Status Unknown
12
Cook County Hosp
Chicago, Illinois, United States, 60612
Status Unknown
13
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States, 60612
Status Unknown
14
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Status Unknown
15
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
Status Unknown
16
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States, 21201
Status Unknown
17
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Status Unknown
18
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Status Unknown
19
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States, 39213
Status Unknown
20
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Status Unknown
21
Children's Hosp at Albany Med Ctr
Albany, New York, United States, 12208
Status Unknown
22
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Status Unknown
23
Cornell Univ Med College
New York, New York, United States, 10021
Status Unknown
24
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
25
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
26
Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
27
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
Status Unknown
28
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States, 10457
Status Unknown
29
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States, 10461
Status Unknown
30
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States, 191341095
Status Unknown
31
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
Status Unknown
32
Med College of Virginia
Richmond, Virginia, United States, 23219
Status Unknown
33
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Status Unknown
34
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, Puerto Rico, 00956
Status Unknown
35
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
Status Unknown
36
San Juan City Hosp
San Juan, Puerto Rico, 009367344
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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