Phase 2
Completed N=37
Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children
Source: ClinicalTrials.gov NCT00364793 ↗Enrolled (actual)
37
Serious AEs
54.1%
Results posted
Apr 2014
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population — 3790; 1998; 2167; 2632 ng/mL
Summary
The primary purpose of this study is to find the dose of Efavirenz for young children. The safety and how the medication is tolerated will also be studied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population |
3790; 1998; 2167; 2632; 391; 445 | — |
| PRIMARY Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population |
129.5; 71.4; 93.8; 130.8 | — |
| PRIMARY Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population |
9.54; 19.69; 13.16; 9.11 | — |
| PRIMARY Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population |
2.07; 2.36; 1.44; 0.66 | — |
| SECONDARY The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants |
7; 6; 3; 5; 21; 7 | — |
| SECONDARY The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants |
6; 6; 2; 4; 18; 6 | — |
| SECONDARY The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants |
8; 7; 4; 7; 26; 8 | — |
| SECONDARY The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants |
4; 4; 3; 4; 15; 5 | — |
| SECONDARY Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants |
5.88; 5.88; 5.88; 5.50; 5.88; -1.89 | — |
| SECONDARY CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants |
1518; 1569; 517; 413; 1144; 259 | — |
| SECONDARY Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants |
28; 26; 12; 7; 24; 14 | — |
| SECONDARY Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events |
1; 0; 1; 0; 2; 2 | — |
| SECONDARY Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population |
0; 0; 1; 0; 1; 8 | — |
| SECONDARY Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants |
2; 4; 1; NA; 7; NA | — |
| SECONDARY Number of Participants With Serum Chemistry Abnormalities - Treated Participants |
10; 9; 4; 5; 28; 5 | — |
| SECONDARY Number of Participants With Hematologic Abnormalities - Treated Participants |
4; 5; 2; 1; 12; 1 | — |
| SECONDARY Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound |
2; 1; 0; 0; 3; 1 | — |
| SECONDARY Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population |
1; 3; 1; 1; 6; 2 | — |
| SECONDARY Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population |
850; 1193; 356; 376; 1.25; 1.54 | — |
| SECONDARY AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population |
1445; 2848; 1038; 1000 | — |
| SECONDARY CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population |
40.7; 35.6; 113.9; 143.0 | — |
| SECONDARY CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population |
7.88; 4.26; 11.36; 10.34 | — |
| SECONDARY Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population |
0.92; 1.41; 1.73; 1.14 | — |
| SECONDARY The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants |
7; 6; 2; 4; 19; 7 | — |
| SECONDARY The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants |
4; 5; 2; 3; 14; 7 | — |
| SECONDARY Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants |
5.88; 5.88; 5.88; 5.50; 5.88; -3.92 | — |
| SECONDARY CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants |
1518; 1569; 517; 413; 1144; -870 | — |
| SECONDARY Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants |
28; 26; 12; 7; 24; 10 | — |
Eligibility Criteria
Inclusion Criteria
- HIV-1 infected; >=3 months of age to =1000 copies/mL
Exclusion Criteria
- Genotypic or phenotypic resistance to EFV, ddl, or FTC/lamivudine (3TC) at screening
Data sourced from ClinicalTrials.gov (NCT00364793). 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.