Terminé

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

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Ce qui est testé

Ritonavir

+ Nelfinavir mesylate
+ Saquinavir
Médicament
Qui peut participer

HIV Infections

De 3 à 16 ans
Comment se déroule l'étude

Étude thérapeutique

Phase 2
Interventionnel

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 29 octobre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

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. 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. \[AS PER AMENDMENT 11/24/99: This study is closed to accrual. All subjects on follow-up (Cohort 1) are given the option of either discontinuing participation in ACTG 397 or participating in the next phase of the study (version 2.0). Those electing to continue participation constitute Cohort 1A. The adjusted Arm 1 regimen consists of SQV-SGC plus ritonavir plus one or two NRTIs. Ritonavir is not provided as part of this study. The Arm 2 regimen study drugs have not changed but the maximum allowable dose of SQV-SGC has increased from 1,200 mg twice-daily to 1,600 mg twice-daily. Participants continue to be followed with physical examinations and laboratory evaluations that include an intensive pharmacokinetics study on Day 14 of the new regimen.\]

Titre officielA Randomized Trial of Two Saquinavir-Containing Combination Treatment Regimens in Children With HIV Infection 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 29 octobre 2021
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design
50 participants à inclureNombre total de participants que l'essai clinique vise à recruter.
Traitement
Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères
Tout sexeLe sexe biologique des participants éligibles à s'inscrire.
De 3 à 16 ansTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Conditions
Pathologie
HIV Infections
Critères

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.



Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.
Cette étude comporte 36 sites
Suspendu
Univ of Alabama at Birmingham / Childrens Hosp of ALBirmingham, United StatesVoir le site
Suspendu
Univ of Alabama at Birmingham - PediatricBirmingham, United States
Suspendu
Long Beach Memorial (Pediatric)Long Beach, United States
Suspendu
Los Angeles County - USC Med CtrLos Angeles, United States

Terminé36 Centres d'Étude