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Completed

NCT Number: NCT01973439

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

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

Completed

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

3 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hôpital Port Royal, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intervention 1: PK assessment while on Twice Daily Abacavir

Other

Week 0

Other names: Ziagen, ABC

Intervention 2: PK assessment while on Once Daily Abacavir

Other

Week 4

Other names: Ziagen, ABC

Primary outcomes

  1. Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing

    Time frame: Week 0

    Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.

  2. Cmax of Abacavir on Twice Daily Dosing

    Time frame: Week 0

    Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.

  3. AUC(0-24) of Abacavir on Once Daily Dosing

    Time frame: Week 4

    Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication

  4. Cmax of Abacavir on Once Daily Dosing

    Time frame: Week 4

    Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.

Sponsors and collaborators

Lead sponsor

PENTA Foundation

Network

Registry information

Official study title

PENTA15: Plasma Pharmacokinetic Study of Once Versus Twice Daily Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV-1 Infection Aged 3 Months to <36 Months

Acronym: PENTA15

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Oct 31, 2013
Registry last updated
Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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