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Clinical Trials/EUCTR2005-004433-18-DE
EUCTR2005-004433-18-DE
Active, not recruiting
Not Applicable

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 - Once versus twice dails abacavir

Fondazione P E N T A0 sites18 target enrollmentApril 27, 2006
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DrugsZiagen oral solutionEpivir oral solution

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Fondazione P E N T A
Enrollment
18
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 27, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Fondazione P E N T A

Eligibility Criteria

Inclusion Criteria

  • •Eligibility: Children aged between 3 and \<36 months who are currently on combination ART including ABC oral solution with or without 3TC oral solution They should have been taking this combination for at least 12 weeks and be 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.
  • •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
  • •F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • •unstable viral load
  • •hypersensitivity reaction to abacavir
  • •children olden than 36 months
  • •withdrawal of informed consent

Outcomes

Primary Outcomes

Not specified

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