Pharmacokinetic (PK) Study of Twice Daily vs Once Daily Lamivudine (3TC) and Abacavir (ABC) as Part of Combination Antiretroviral Therapy (ART) in HIV Infected Children

Phase 1

Completed

• Conditions: HIV Infection
• Interventions: Drug: ABC Twice Daily; Drug: ABC Once Daily; Drug: 3TC Once Daily; Drug: 3TC Twice Daily

• Registration Number: NCT01982396
• Lead Sponsor: PENTA Foundation

Brief Summary

Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2004-02
• Study Completion: 2004-03
• Study First Submitted: 2013-10-25
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-05
• Last Update Submitted: 2013-11-05
• Study First Posted: 2013-11-13
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Children with definitive HIV infection
• Age > 2 and < 13 years
• Currently on combination ART including 3TC and / or ABC, for at least 6 months, with stable CD4 cell count and HIV RNA viral load and expected to stay on this regimen for at least a further 3 months.

Exclusion Criteria

• • Intercurrent illness

  • Receiving concomitant therapy except prophylaxis against Pneumocystis carinii pneumonia (PCP)
  • Abnormal renal or liver function (grade 3 or above)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Twice daily	ABC Twice Daily	-
Once daily	ABC Once Daily	-
Once daily	3TC Once Daily	-
Twice daily	3TC Twice Daily	-

Primary Outcome Measures

Name	Time	Method
AUC of abacavir after qd and bid dosing	week 0 and week 4
Cmin of abacavir after qd and bid dosing	week 0 and week 4
Cmax of abacavir after qd and bid dosing	week 0 and week 4
Area Under Curve (AUC) of lamivudine after qd and bid dosing	week 0 and Week 4
Cmin of lamivudine after qd and bid dosing	week 0 and week 4
Cmax of lamivudine after qd and bid dosing	week 0 and week 4

Secondary Outcome Measures

Name	Time	Method
To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens	Week 0 and week 4

Trial Locations

Locations (2)

Great Ormond Street Hospital; 🇬🇧 London, United Kingdom

St. Mary's Hospital; 🇬🇧 London, United Kingdom