Fellow:
Immaculate Nankya
Collaborators:
Name |
Country |
Institution
|
Immaculate Nankya |
Uganda |
Joint clinical Research Center |
Objectives:
1. To determine the prevalence of low-frequency HIV transmitted drug resistant mutations in infants born to HIV-sero positive mothers taking triple combination therapy in the Elimination of Mother to Child Transmission of HIV (EMTCT) program.
2. To evaluate the effect of initiation of triple combination ART to HIV positive infants with low-frequent polymorphisms on subsequent response to therapy over a two year period.
3. To determine co-receptor evolution in mother-infant pairs failing on ART
4. To access socio-economic factors associated with poor adherence to ART in mother infant pairs failing with a viral load greater than 1000 copies/ml.
5. To assess the effectiveness of IAC in mother-infant pairs in mothers and infants whose viral load is greater than 1000 copies/ml on a follow up viral load test
6. To determine the evolution of minority and majority HIV drug resistant variants during the course of IAC in mother-infant pairs
Sites:
Joint Clinical Research Centre, Kampala, Uganda
Study Design:
A randomized open label non-inferiority controlled clinical trial.
Subjects:
HIV sero-positive babies born to HIV positive mothers.
Outcomes:
Primary end point: Detection of a viral load greater than 1000 copies. These patients then based on the regimen they are taking, a drug resistance test will be done and switched to a regimen as dictated by the drug resistance results.
Secondary endpoint: Determination of levels of adherence in patients with a detectable viral load greater than 1000 copies/ml.