SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03760458

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age

The purpose of this study is to examine the pharmacokinetics, safety, and tolerability of abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in HIV-1-infected children less than 12 years of age.

NCT03760458 HIV Infections
MeSH: HIV Infections

2 Interventions

Name: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets

Description: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food

Type: Drug

Weight Band #1 (6 to less than 10 kg) Weight Band #2 (10 to less than 14 kg) Weight Band #3 (14 to less than 20 kg) Weight Band #4 (20 to less than 25 kg)

Name: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)

Description: Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food

Type: Drug

Weight Band #5 (25 kg or greater)


Primary Outcomes

Description: Based on analysis of intensive PK samples collected at Week 1 and compared within each weight band to the PK targets specified in the study protocol

Measure: Geometric mean area under the plasma concentration-time curve over 24 hours at steady-state (AUC0-24h) for ABC, DTG, and 3TC

Time: Measured at Week 1

Description: Based on analysis of intensive PK samples collected at Week 1

Measure: Geometric mean maximum plasma concentration (Cmax) for ABC, DTG, and 3TC

Time: Measured at Week 1

Description: Based on analysis of intensive PK samples collected at Week 1 and compared within each weight band to the PK targets specified in the study protocol

Measure: Geometric mean concentration at 24 hours post-dose (C24h) for ABC, DTG, and 3TC

Time: Measured at Week 1

Description: Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017

Measure: Number of participants who had adverse events

Time: Measured through Week 24

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had Grade 3 or Grade 4 adverse events assessed as related to study drug

Time: Measured through Week 24

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had Grade 5 adverse events assessed as related to study drug

Time: Measured through Week 24

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had serious adverse events assessed as related to study drug

Time: Measured through Week 24

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had adverse events assessed as related to study drug that lead to permanent discontinuation of study drug

Time: Measured through Week 24

Secondary Outcomes

Description: Derived from population PK modeling with sampling

Measure: Area under the plasma concentration-time curve over 24 hours at steady-state (AUC0-24h) for ABC, DTG, and 3TC

Time: Measured through Week 48

Description: Derived from population PK modeling with sampling

Measure: Concentration at time 0 (pre-dose) (C0h) for ABC, DTG, and 3TC

Time: Measured through Week 48

Description: Derived from population PK modeling with sampling

Measure: Concentration at 24 hours post-dose (C24h) for ABC, DTG, and 3TC

Time: Measured through Week 48

Description: Derived from population PK modeling with sampling

Measure: Maximum plasma concentration (Cmax) for ABC, DTG, and 3TC

Time: Measured through Week 48

Description: Derived from population PK modeling with sampling

Measure: Time to maximum concentration (Tmax) for ABC, DTG, and 3TC

Time: Measured through Week 48

Description: Derived from population PK modeling with sampling

Measure: Apparent oral clearance (CL/F) for ABC, DTG, and 3TC

Time: Measured through Week 48

Description: Derived from population PK modeling with sampling

Measure: Half-life (t1/2) for ABC, DTG, and 3TC

Time: Measured through Week 48

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had adverse events

Time: Measured through Week 48

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had Grade 3 or Grade 4 adverse events assessed as related to study drug

Time: Measured through Week 48

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had Grade 5 adverse events assessed as related to study drug

Time: Measured through Week 48

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had serious adverse events assessed as related to study drug

Time: Measured through Week 48

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had adverse events assessed as related to study drug that lead to permanent discontinuation of study drug

Time: Measured through Week 48

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had adverse events

Time: Measured through Week 144

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had Grade 3 or Grade 4 adverse events assessed as related to study drug

Time: Measured through Week 144

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had Grade 5 adverse events assessed as related to study drug

Time: Measured through Week 144

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had serious adverse events assessed as related to study drug

Time: Measured through Week 144

Description: Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Measure: Number of participants who had adverse events assessed as related to study drug that lead to permanent discontinuation of study drug

Time: Measured through Week 144

Description: Based on laboratory evaluations

Measure: Proportion of participants with HIV-1 RNA levels meeting virologic response criteria

Time: Measured through Week 48

Description: Based on laboratory evaluations

Measure: Proportion of participants with HIV-1 RNA levels meeting virologic response criteria

Time: Measured through Week 144

Description: Based on laboratory evaluations

Measure: Number of participant with HIV-1 RNA greater than or equal to 200 copies/mL at Weeks 4, 24, and 48 (snapshot algorithm)

Time: Measured through Week 48

Description: Based on laboratory evaluations

Measure: Number of participants with HIV-1 RNA greater than or equal to 50 copies/mL at Weeks 4, 24, and 48 (snapshot algorithm)

Time: Measured through Week 48

Description: Based on laboratory evaluations

Measure: Median changes (with IQR) in CD4+ cell count and percentage at Weeks 4, 24, and 48

Time: Measured through Week 48

Description: Based on laboratory evaluations

Measure: Median changes (with IQR) in CD4+ cell count and percentage through Week 144

Time: Measured through Week 144

Description: Based on laboratory evaluations

Measure: Median changes (with IQR) in total cholesterol, HDL, LDL, and triglycerides at Weeks 24 and 48

Time: Measured through Week 48

Description: Based on questionnaire responses

Measure: Aggregated data on parent/guardian reported adherence to study drug at Weeks 4, 24, and 48

Time: Measured through Week 48

Description: Based on questionnaire responses

Measure: Aggregated data on parent/guardian reported tolerability (i.e., palatability and acceptability) of study drug at Weeks 4, 24, and 48

Time: Measured through Week 48

Description: Based on laboratory evaluations

Measure: ARV resistance mutations at time of virologic failure (and at entry for children with resistance identified at time of virologic failure)

Time: Measured through Week 48

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 M184V

- Documented resistance to ABC, DTG, or 3TC - Note: Testing to rule out resistance is not required, and the M184V resistance mutation is not exclusionary. --- M184V ---



HPO Nodes