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Clinical Trials/EUCTR2005-004433-18-GB
EUCTR2005-004433-18-GB
Active, not recruiting
Phase 1

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

PENTA0 sites18 target enrollmentDecember 19, 2005
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ConditionsPaediatric HIV infectionMedDRA version: 8 Level: PT Classification code 10020161

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Paediatric HIV infection
Sponsor
PENTA
Enrollment
18
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 19, 2005
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
PENTA

Eligibility Criteria

Inclusion Criteria

  • •Infants and children with confirmed presence of HIV infection.
  • •Infants and children aged 3 to \<36 months
  • •Parents able / willing to give consent
  • •Currently on combination ART including ABC oral solution with or without 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) or 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
  • •CD4\+ cell percent – children should have stable or rising CD4\+ cell percent prior to study entry and their CD4\+ cell percent should not be expected to fall within the next 12 weeks.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

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

Outcomes

Primary Outcomes

Not specified

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