Infected with Human Immunodeficiancy Virus - (HIV-Infection)
Conditions
Interventions
Trade Name: Strategy trial therefore this section is NOT APPLICABLE. All products that are to be used in the trial are alreay licensed. Please find enclosed a copy of the DDX.
Product Name: N/A
Produc
Sponsors
PENTA Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 2-15 years inclusive. 2. Parents/guardians, and children where appropriate, willing and able to give informed consent . 3. Children currently on the same regimen of 3 or more antiretroviral drugs for at least 24 weeks. 4. Children and parents prepared to restart the same regimen after treatment interruption if CD4% falls to 30% with TLC >1000 (at least one month apart); most recent two CD4% should be stable (different by no more than 4%). 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Cannot and unwilling to attend regularly 2. Unwilling to restart ART if CD4% or count indicates this is necessary. 3. Intercurrent illness (randomisation can take place after the illness) 4. Pregnancy or risk of pregnancy in girls of child bearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the role of planned treatment interruptions (PTIs) in the management of HIV infected children who have responded well to antiretroviral therapy and to determine whether children undergoing a PTI are disadvantaged clinically, immunologically or virologically by having spent periods of time off antiretroviral therapy (ART).;Primary end point(s): CD4% < 15% new CDC stage C diagnosis;Secondary Objective: 1. To assess HIV-specific immune responses during and after interruption of ART, compared with continuous ART, in an immunology and Virology substudy. 2. To assess the pharmacokinetics of agents with long half-lives - NNRTI and Lamivudine and their association with the development of resistance in the context of planned treatment interruptions. | — |
Countries
Ireland, Spain
Outcome results
None listed