A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children
NCT ID: NCT00000913
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2001-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients are randomized to one of two study arms. Patients in Arm 1 receive SQV-SGC plus two \[AS PER AMENDMENT 11/24/99: one or two\] NRTIs of choice. Patients in Arm 2 receive SQV-SGC plus NFV plus one or two NRTIs of choice. All participants are evaluated by physical examinations and laboratory tests during the study and are followed for incidence of death, cancer, or fetal abnormality. NRTIs are not provided as part of this study. \[AS PER AMENDMENT 11/24/99: This study is closed to accrual. All subjects on follow-up (Cohort 1) are given the option of either discontinuing participation in ACTG 397 or participating in the next phase of the study (version 2.0). Those electing to continue participation constitute Cohort 1A. The adjusted Arm 1 regimen consists of SQV-SGC plus ritonavir plus one or two NRTIs. Ritonavir is not provided as part of this study. The Arm 2 regimen study drugs have not changed but the maximum allowable dose of SQV-SGC has increased from 1,200 mg twice-daily to 1,600 mg twice-daily. Participants continue to be followed with physical examinations and laboratory evaluations that include an intensive pharmacokinetics study on Day 14 of the new regimen.\]
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ritonavir
Nelfinavir mesylate
Saquinavir
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
3 Years
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark Kline
Role: STUDY_CHAIR
Courtney Fletcher
Role: STUDY_CHAIR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univ of Alabama at Birmingham / Childrens Hosp of AL
Birmingham, Alabama, United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States
Long Beach Memorial (Pediatric)
Long Beach, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Children's Hosp of Oakland
Oakland, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Yale Univ Med School
New Haven, Connecticut, United States
Howard Univ Hosp
Washington D.C., District of Columbia, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Palm Beach County Health Dept
Riviera Beach, Florida, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, United States
Cook County Hosp
Chicago, Illinois, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States
Children's Hosp at Albany Med Ctr
Albany, New York, United States
North Shore Univ Hosp
Great Neck, New York, United States
Cornell Univ Med College
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States
Harlem Hosp Ctr
New York, New York, United States
State Univ of New York at Stony Brook
Stony Brook, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Med College of Virginia
Richmond, Virginia, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, , Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , Puerto Rico
San Juan City Hosp
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Brundage RC, Kline MW, Lindsey J, Fenton T, Fletcher CV. Pharmacokinetics of saquinavir (SQV) with nelfinavir (NFV) or ritonavir (RTV) in HIV-infected children. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 728)
Kline MW, Fletcher CV, Lindsey JC, Fenton T. A randomized trial of two saquinavir (SQV-SGC)-containing combination treatment regimens in HIV-infected children. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 [Poster 694]
Kline MW, Fletcher CV, Lindsey JC, Fenton T. A randomized trial of combination therapy with saquinavir soft gelatin capsules (SQV) in HIV-infected children. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 683)
Brundage RC, Kline MW, Lindsey JC, Fenton T, Fletcher CV. Pharmacokinetics (PK) of saquinavir (SQV) and nelfinavir (NFV) in a twice-daily (BID) regimen in HIV-infected children. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 [Poster 718]
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11353
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 397
Identifier Type: -
Identifier Source: org_study_id