A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This single arm study will assess the pharmacokinetics, safety and activity of saquinavir (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination with ritonavir, in HIV-1 infected infants and children between the ages of 4 months and 6 years. Patients will commence treatment with saquinavir 50mg/kg bid plus ritonavir 2.5mg/kg or 3.0mg/kg (dependent on body weight), and a background antiretroviral regimen. If drug exposures are found to be dissimilar to those previously seen in older children and adults, or are associated with toxicities, subsequent dose adjustments will be made. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients

NCT01638650

HIV Infections

COMPLETED PHASE1

The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children

NCT00002380

HIV Infections

COMPLETED PHASE1

Evaluating the Safety and Tolerability of Etravirine in HIV-1 Infected Infants and Children

NCT01504841

HIV Infections

COMPLETED PHASE1/PHASE2

Safety of Saquinavir and High Doses of Lopinavir/Ritonavir in Children With HIV

NCT00084058

HIV Infections

COMPLETED PHASE1/PHASE2

Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment

NCT00012519

HIV Infections

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

ritonavir

Intervention Type DRUG

2.5-3.0mg/kg po bid (starting dose) for 48 weeks

saquinavir [Invirase]

Intervention Type DRUG

50mg/kg po bid (starting dose) for 48 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ritonavir

2.5-3.0mg/kg po bid (starting dose) for 48 weeks

Intervention Type DRUG

saquinavir [Invirase]

50mg/kg po bid (starting dose) for 48 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* infants and children, 4 months to \<6 years;
* confirmed HIV-1 infection;
* patients for whom saquinavir/ritonavir together with \>=2 background ARVs is considered appropriate.

Exclusion Criteria

* body weight \>4kg/8.8 pounds;
* use of any concomitant medications that may interfere with the pharmacokinetics of saquinavir or ritonavir;
* malabsorption, severe chronic diarrhea or vomiting within 28 days of the study.

Minimum Eligible Age

4 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No