Phase 2
Completed N=18
A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.
Source: ClinicalTrials.gov NCT00623597 ↗Enrolled (actual)
18
Serious AEs
16.7%
Results posted
Jan 2016
Primary outcomePrimary: Plasma Trough Concentrations (Ctrough) for Saquinavir — 645; 1860 ng/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Trough Concentrations (Ctrough) for Saquinavir |
645; 1860 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Saquinavir |
18.7; 38 | — |
| PRIMARY Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) |
1; 2; 3; 5; 9; 14 | — |
| PRIMARY Change In Hematocrit From Baseline |
0.01; -0; -0; 0.03; -0.01; 0 | — |
| PRIMARY Change In Hemoglobin, Total Protein And Total Albumin From Baseline |
-0; 1; 1; 6; 0; 2 | — |
| PRIMARY Change In White Blood Cell (WBC), Platelet, Basophil, Lymphocyte, Monocyte, Neutrophil And Eosinophil Cell Counts From Baseline |
-3; -1; -1.5; -2.1; -0.9; -1.2 | — |
| PRIMARY Change In Red Blood Cell (RBC) Counts From Baseline |
-0.18; -0.07; -0.1; 0.02; -0.16; -0.12 | — |
| PRIMARY Change In Creatine Kinase (CK), Serum Glutamic Oxaloacetic Transaminase (SGOT), Alkaline Phosphatase (ALP), Serum Glutamic-Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) Counts From Baseline |
112; -12; 11; 257; -7; 43 | — |
| PRIMARY Change In Total Bilirubin, Creatinine, Uric Acid From Baseline |
2; 2; 2; 1; 2; 1 | — |
| PRIMARY Change In Blood Urea Nitrogen (BUN), Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL Cholesterol), Triglycerides, Calcium, Potassium, Sodium, Chloride, Phosphate, Fasting Glucose From Baseline |
-1.5; 1; 0.5; 0.4; 1.1; 0.9 | — |
| PRIMARY Change In Hematuria, Glycosuria And Proteinuria From Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Plasma Trough Concentrations (Ctrough) for Ritonavir |
577; 995 | — |
| SECONDARY Maximum Observed Concentration (Cmax) for Saquinavir and Ritonavir |
2910; 5570; 2050; 3370 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to Twelve Hours (AUC0-12h) for Ritonavir |
13.6; 21.8 | — |
| SECONDARY Change From Baseline in Mean Human Immunodeficiency Virus Viral Load |
-0.75; -1.81; -1.61; -1.27; -1.39; -1.36 | — |
| SECONDARY Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <400 Copies/mL |
1; 5; 6; 2; 13; 15 | — |
| SECONDARY Number of Participants With Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA) <50 Copies/mL |
0; 4; 4; 2; 11; 13 | — |
| SECONDARY Number of Participants With >1 Log Decrease From Baseline in Human Immunodeficiency Virus (HIV) -Ribonucleic Acid (RNA ) |
1; 7; 8; 1; 8; 9 | — |
| SECONDARY Number of Participants With Virological Failure |
2; 1; 3; 2; 0; 2 | — |
| SECONDARY Change From Baseline in Cluster Differentiation Antigen 4 (CD4) Lymphocyte Count |
94.90; -34.53; -8.65; -50.07; 126.11; 90.87 | — |
| SECONDARY Change From Baseline in Cluster Differentiation Antigen 8 (CD8) Lymphocyte Count |
-200.49; -3.50; -42.90; -92.07; 40.52; 14.00 | — |
Eligibility Criteria
Inclusion Criteria
- infants and children, 4 months to =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.
Data sourced from ClinicalTrials.gov (NCT00623597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.