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Completed

NCT Number: NCT01982396

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

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.

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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

2 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Great Ormond Street Hospital, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

ABC Twice Daily

Drug

ABC Once Daily

Drug

3TC Once Daily

Drug

3TC Twice Daily

Drug

Primary outcomes

  1. Area Under Curve (AUC) of lamivudine after qd and bid dosing

    Time frame: week 0 and Week 4

  2. Cmin of lamivudine after qd and bid dosing

    Time frame: week 0 and week 4

  3. Cmax of lamivudine after qd and bid dosing

    Time frame: week 0 and week 4

  4. AUC of abacavir after qd and bid dosing

    Time frame: week 0 and week 4

  5. Cmin of abacavir after qd and bid dosing

    Time frame: week 0 and week 4

  6. Cmax of abacavir after qd and bid dosing

    Time frame: week 0 and week 4

Secondary outcomes

  1. To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens

    Time frame: Week 0 and week 4

Other outcomes

  1. To describe patient and family acceptability of and adherence to once daily compared to twice daily dosing

    Time frame: week -2 and week 24

Sponsors and collaborators

Lead sponsor

PENTA Foundation

Network

Registry information

Official study title

Pharmacokinetic Study of Twice Daily vs Once Daily Lamivudine and Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV Infection

Acronym: PENTA 13

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Nov 13, 2013
Registry last updated
Nov 13, 2013

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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