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

NCT00000913 | Completed Phase 2

• 2 other identifiers: ACTG 39711353
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 36

Brief 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.

Conditions

HIV Infections

Keywords

Saquinavir; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load

Interventions

Ritonavir DRUG

Nelfinavir mesylate DRUG

Saquinavir DRUG

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (36)

Univ of Alabama at Birmingham / Childrens Hosp of AL

Birmingham, Alabama, 352330011, United States

Location

Univ of Alabama at Birmingham - Pediatric

Birmingham, Alabama, 35233, United States

Location

Long Beach Memorial (Pediatric)

Long Beach, California, 90801, United States

Location

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

Children's Hosp of Oakland

Oakland, California, 946091809, United States

Location

UCSF / Moffitt Hosp - Pediatric

San Francisco, California, 941430105, United States

Location

Yale Univ Med School

New Haven, Connecticut, 06504, United States

Location

Howard Univ Hosp

Washington D.C., District of Columbia, 20060, United States

Location

Univ of Miami (Pediatric)

Miami, Florida, 33161, United States

Location

Palm Beach County Health Dept

Riviera Beach, Florida, 33404, United States

Location

Emory Univ Hosp / Pediatrics

Atlanta, Georgia, 30306, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Univ of Illinois College of Medicine / Pediatrics

Chicago, Illinois, 60612, United States

Location

Chicago Children's Memorial Hosp

Chicago, Illinois, 606143394, United States

Location

Tulane Univ / Charity Hosp of New Orleans

New Orleans, Louisiana, 701122699, United States

Location

Univ of Maryland at Baltimore / Univ Med Ctr

Baltimore, Maryland, 21201, United States

Location

Children's Hosp of Boston

Boston, Massachusetts, 021155724, United States

Location

Baystate Med Ctr of Springfield

Springfield, Massachusetts, 01199, United States

Location

Univ of Mississippi Med Ctr

Jackson, Mississippi, 39213, United States

Location

Univ of Medicine & Dentistry of New Jersey / Univ Hosp

Newark, New Jersey, 071032714, United States

Location

Children's Hosp at Albany Med Ctr

Albany, New York, 12208, United States

Location

North Shore Univ Hosp

Great Neck, New York, 11021, United States

Location

Cornell Univ Med College

New York, New York, 10021, United States

Location

Columbia Presbyterian Med Ctr

New York, New York, 10032, United States

Location

Incarnation Children's Ctr / Columbia Presbyterian Med Ctr

New York, New York, 10032, United States

Location

Harlem Hosp Ctr

New York, New York, 10037, United States

Location

State Univ of New York at Stony Brook

Stony Brook, New York, 117948111, United States

Location

Bronx Lebanon Hosp Ctr

The Bronx, New York, 10457, United States

Location

Bronx Municipal Hosp Ctr/Jacobi Med Ctr

The Bronx, New York, 10461, United States

Location

Saint Christopher's Hosp for Children

Philadelphia, Pennsylvania, 191341095, United States

Location

Med Univ of South Carolina

Charleston, South Carolina, 294253312, United States

Location

Med College of Virginia

Richmond, Virginia, 23219, United States

Location

Children's Hospital & Medical Center / Seattle ACTU

Seattle, Washington, 981050371, United States

Location

Ramon Ruiz Arnau Univ Hosp / Pediatrics

Bayamón, 00956, Puerto Rico

Location

Univ of Puerto Rico / Univ Children's Hosp AIDS

San Juan, 009365067, Puerto Rico

Location

San Juan City Hosp

San Juan, 009367344, Puerto Rico

Location

Related 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)

  BACKGROUND

• 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]

  BACKGROUND

• 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)

  BACKGROUND

• 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]

  BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Ritonavir; Nelfinavir; Saquinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinolines

Study Officials

• Mark Kline

  STUDY CHAIR

• Courtney Fletcher

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: April 1, 2001
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (33); PR (3)