PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months

Phase 1

Completed

• Conditions: HIV Infection

• Registration Number: NCT01973439
• Lead Sponsor: PENTA Foundation

Brief Summary

To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir in HIV-1-infected infants and children aged 3 months to 36 months

The secondary objectives of PENTA15 were:

To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in HIV-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine in combination with abacavir

To compare age-related differences in the PK parameters of q24h versus q12h dosing of abacavir and lamivudine infants and children in 3 age groups (≥3 to \<12 months, ≥12 to \<24 months and ≥24 to \<36 months)

To describe child and family acceptability of and adherence to q24h compared to q12h dosage regimens of abacavir and lamivudine

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2008-06
• Study Completion: 2009-06
• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-31
• Results First Submitted: 2013-12-04
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-03
• Last Update Submitted: 2014-02-03
• Results First Posted: 2014-03-20
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Infants and children with confirmed presence of HIV-1 infection

• Infants and children aged 3 to <36 months

• Parents/guardians able and willing to give written, informed consent

• Currently on combination ART including Abacavir (ABC) oral solution with or without Lamivudine (3TC) oral solution, for at least 12 weeks and expected to stay on this regimen for at least a further 12 weeks.

• HIV-1 RNA viral load either;

  • suppressed HIV-1 RNA viral load (i.e. <400 copies/ml)
  • non-suppressed, but low, HIV-1 RNA viral load (i.e. 400-20 000 copies/ml). The non-suppressed children should have had a stable or decreasing HIV-1 RNA viral load prior to study entry and should be considered to be still gaining benefit from the current regimen

• Stable or rising CD4+ cell percent prior to study entry and should not be expected to fall within the next 12 weeks.

Exclusion Criteria

• Intercurrent illness
• Receiving concomitant therapy except prophylactic antibiotics
• Abnormal renal or liver function (grade 3 or above)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing	Week 0	Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
Cmax of Abacavir on Twice Daily Dosing	Week 0	Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
AUC(0-24) of Abacavir on Once Daily Dosing	Week 4	Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication
Cmax of Abacavir on Once Daily Dosing	Week 4	Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.

Trial Locations

Locations (10)

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

Hôpital Port Royal; 🇫🇷 Paris, France

Evelina Children's Hospital; 🇬🇧 London, United Kingdom

Hôpital Robert Debré; 🇫🇷 Paris, France

Clinica Pediatrica, Università di Padova; 🇮🇹 Padova, Italy

Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital; 🇩🇪 Munich, Germany

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario; 🇪🇸 Getafe, Spain

Birmingham Heartlands Hospital; 🇬🇧 Birmingham, United Kingdom

Hospital Gregorio Maranon; 🇪🇸 Madrid, Spain