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 (PENTA 13)

PENTA Foundation

Status and phase: Completed; Phase 1

Conditions: HIV Infection

Treatments: Drug: ABC Once Daily; Drug: 3TC Twice Daily; Drug: ABC Twice Daily; Drug: 3TC Once Daily

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01982396

PENTA 13

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 2 to 13 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Twice daily

Active Comparator group

Treatment:

Drug: ABC Twice Daily

Drug: 3TC Twice Daily

Once daily

Experimental group

Treatment:

Drug: 3TC Once Daily

Drug: ABC Once Daily