Efficacy of dolutegravir based antiretroviral regimen in HIV positive children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Department of Paediatrics
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Proportion of patients having viral suppression after 6 months of treatment with Dolutegravir based regimen.
Study Overview
Brief Summary
This study is an observational study aimed at finding the efficacy of Dolutegravir based antiretroviral regimen in HIV positive children aged between 1 month to 15 years. Study will be conducted in Paediatric HIV clinic, Maulana Azad Medical College and associated Lok Nayak Hospital, Delhi.
Primary outcome of the study will be the proportion of patients having viral suppression after 6 months of treatment with Dolutegravir based regimen.
Secondary outcomes of the study will be:
-
Proportion of patients having adverse events (if any) following treatment with Dolutegravir based regimen and grading of the severity of adverse events.
-
Proportion of patients adherent to treatment with Dolutegravir based regimen.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 1.00 Month(s) to 15.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients substituted to Dolutegravir based regimen from older treatment regimens.
- •Newly diagnosed HIV positive children started on DTG regimen.
Exclusion Criteria
- •Coinfection with Tuberculosis, Hepatitis B and Hepatitis C.
- •Patients with chronic liver disease and auto immune diseases.
Outcomes
Primary Outcomes
Proportion of patients having viral suppression after 6 months of treatment with Dolutegravir based regimen.
Time Frame: 6 months
Secondary Outcomes
- 1. Proportion of patients having adverse events (if any) following treatment with dolutegravir based regimen and grading of severity of adverse events.(2. Proportion of patients adherent to treatment with Dolutegravir based regimen.)
Investigators
Vijaya lakshmi Minumanuri
Maulana Azad Medical College