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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000913 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Ritonavir Drug: Nelfinavir mesylate Drug: Saquinavir |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Pharmacokinetics Study |
Official Title: | A Randomized Trial of Two Saquinavir-Containing Combination Treatment Regimens in Children With HIV Infection |
Estimated Enrollment: | 50 |
Study Completion Date: | August 2007 |
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.]
Ages Eligible for Study: | 3 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Your child may be eligible for this study if he or she:
Exclusion Criteria
Your child will not be eligible if he or she:
Study Chair: | Mark Kline | |
Study Chair: | Courtney Fletcher |
Study ID Numbers: | ACTG 397 |
Study First Received: | November 2, 1999 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00000913 |
Health Authority: | United States: Federal Government |
Saquinavir Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Seropositivity Saquinavir Ritonavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Nelfinavir Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents Communicable Diseases RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action |
Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |