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Protease Inhibitor

Arm A - 4weeks - less than 2 years old (FPV/RTV bid) for HIV/AIDS

Phase 2
Waitlist Available
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and weeks 4, 12, 24, 36, and 48
Awards & highlights

Study Summary

This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years old.

Eligible Conditions
  • HIV/AIDS
  • Human Immunodeficiency Virus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and weeks 4, 12, 24, 36, and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and weeks 4, 12, 24, 36, and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48
Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48
+10 more
Secondary outcome measures
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit
Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or the Occurrence of Adverse Events
+25 more
Other outcome measures
Number of Participants Who Permanently Discontinued the Treatment Due to Adverse Event
Number of Participants With Clinical Chemistry Toxicities
Number of Participants With Hematology Toxicities
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B- 4weeks - less than 2 years old (FPV bid)Experimental Treatment1 Intervention
Cohort 2B - 4weeks - less than 6 months old. Fosamprenavir (FPV) 50 mg/mL oral suspension twice daily (BID) Cohort 1B - 6 months - less than 2yrs old. Fosamprenavir (FPV) 50 mg/mL oral suspension twice daily (BID)
Group II: Arm A - 4weeks - less than 2 years old (FPV/RTV bid)Experimental Treatment2 Interventions
Cohort 2A - 4weeks - less than 6 months old. Fosamprenavir (FPV) 50 mg/mL oral suspension/ritonavir (RTV) 80 mg/mL oral solution twice daily (BID) Cohort 1A - 6 months - less than 2yrs old. Fosamprenavir (FPV) 50 mg/mL oral suspension/ritonavir (RTV) 80 mg/mL oral solution twice daily (BID)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fosamprenavir
FDA approved
Fosamprenavir
FDA approved

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
360 Previous Clinical Trials
468,520 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,757 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,595 Previous Clinical Trials
6,143,871 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
2003. "Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00071760.
~3 spots leftby Apr 2025
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