A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children

HIV Infections Clinical Trial

Official title:

A Randomized Trial of Two Saquinavir-Containing Combination Treatment Regimens in Children With HIV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000913
• Other study ID #: ACTG 397
• Secondary ID: 11353
• Status: Completed
• Phase: Phase 2
• Est. completion date: April 2001

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Clinical trials in adults and children suggest that SQV-SGC has advantages over other protease inhibitors in terms of tolerability, safety, and effectiveness in patients who have failed therapy with other protease inhibitors. [AS PER AMENDMENT 11/24/99: Pharmacokinetic data from this study demonstrate lower than expected plasma SQV exposures, particularly in Arm 1. Based on these data, patients in the study will be offered the opportunity to adjust their doses. Ritonavir added to the Arm 1 regimen is expected to significantly increase SQV-SGC plasma levels and allow twice-daily dosing for SQV-SGC.]

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.]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infections

Intervention

Drug:
• Ritonavir

• Nelfinavir mesylate

• Saquinavir

Locations

Country	Name	City	State
Puerto Rico	Ramon Ruiz Arnau Univ Hosp / Pediatrics	Bayamon
Puerto Rico	San Juan City Hosp	San Juan
Puerto Rico	Univ of Puerto Rico / Univ Children's Hosp AIDS	San Juan
United States	Children's Hosp at Albany Med Ctr	Albany	New York
United States	Emory Univ Hosp / Pediatrics	Atlanta	Georgia
United States	Univ of Maryland at Baltimore / Univ Med Ctr	Baltimore	Maryland
United States	Univ of Alabama at Birmingham - Pediatric	Birmingham	Alabama
United States	Univ of Alabama at Birmingham / Childrens Hosp of AL	Birmingham	Alabama
United States	Children's Hosp of Boston	Boston	Massachusetts
United States	Bronx Lebanon Hosp Ctr	Bronx	New York
United States	Bronx Municipal Hosp Ctr/Jacobi Med Ctr	Bronx	New York
United States	Med Univ of South Carolina	Charleston	South Carolina
United States	Chicago Children's Memorial Hosp	Chicago	Illinois
United States	Cook County Hosp	Chicago	Illinois
United States	Univ of Illinois College of Medicine / Pediatrics	Chicago	Illinois
United States	North Shore Univ Hosp	Great Neck	New York
United States	Univ of Mississippi Med Ctr	Jackson	Mississippi
United States	Long Beach Memorial (Pediatric)	Long Beach	California
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	Univ of Miami (Pediatric)	Miami	Florida
United States	Yale Univ Med School	New Haven	Connecticut
United States	Tulane Univ / Charity Hosp of New Orleans	New Orleans	Louisiana
United States	Columbia Presbyterian Med Ctr	New York	New York
United States	Cornell Univ Med College	New York	New York
United States	Harlem Hosp Ctr	New York	New York
United States	Incarnation Children's Ctr / Columbia Presbyterian Med Ctr	New York	New York
United States	Univ of Medicine & Dentistry of New Jersey / Univ Hosp	Newark	New Jersey
United States	Children's Hosp of Oakland	Oakland	California
United States	Saint Christopher's Hosp for Children	Philadelphia	Pennsylvania
United States	Med College of Virginia	Richmond	Virginia
United States	Palm Beach County Health Dept	Riviera Beach	Florida
United States	UCSF / Moffitt Hosp - Pediatric	San Francisco	California
United States	Children's Hospital & Medical Center / Seattle ACTU	Seattle	Washington
United States	Baystate Med Ctr of Springfield	Springfield	Massachusetts
United States	State Univ of New York at Stony Brook	Stony Brook	New York
United States	Howard Univ Hosp	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (4)

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)

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]

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)

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]