Etiology of Treatment Failure in HIV Positive Children and Adolescents on Boosted Protease Inhibitor-based Regimens (ATF)
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|ClinicalTrials.gov Identifier: NCT02689895|
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : February 13, 2018
Highly active antiretroviral therapy (HAART) transformed a once fatal condition into a chronic, manageable condition. However, it is estimated that 20-40% of patients on 2nd line treatment (2 nucleotide reverse transcriptase inhibitors [NRTIs] and a boosted protease inhibitor [PI]) are failing treatment. Figures are thought to be higher in children and adolescents.
The reason why patients are failing 2nd line treatment is not exactly known. Failure has been previously attributed to poor adherence. However, some literature shows that some patients on boosted PIs achieve and maintain viral suppression despite suboptimal adherence (adherence of 80- 95%). Viral factors, like drug resistance, are also implicated in treatment failure. However, boosted PIs have high genetic barrier to clinically significant mutations. Therefore, a virus would have to harbour multiple PI mutations for the virus to have reduced susceptibility to boosted PI regimens. Pharmacological factors such as suboptimal dosing, impaired absorption and drug interactions may also be responsible for treatment failure.
If sub-optimal adherence is the reason why children are failing 2nd line treatment, then restoring optimal adherence should result in viral suppression, failure of which might mean that other causes are contributing to failure. If resistance is the cause of treatment failure, then this study will provide evidence for advocating for resistance testing and the use of 3rd line antiretroviral drugs. If children with adequate adherence demonstrate inadequate drug levels in their plasma, then this study will provide evidence to advocate for studies to examine reasons for inadequate drug exposure amongst HIV-infected children. These studies are paramount to optimizing dosing algorithms in this population.
This proposed study will help elucidate reasons for treatment failure in HIV-infected children on second line treatment with the aim of ultimately optimizing antiretroviral treatment strategies for this important group.
|Condition or disease||Intervention/treatment||Phase|
|HIV||Other: modified directly administered anti-retroviral therapy (mDAART)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Etiology of Treatment Failure in HIV Positive Children and Adolescents on Boosted Protease Inhibitor-based Regimens|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 31, 2017|
Research assistants visit participants at home, and send SMS texts on scheduled days for 3 months to encourage adherence to ART. Pill charts, visit charts and text charts are completed. this is called modified directly administered anti-retroviral therapy (mDAART). In addition to the intervention, participants receive standard care at their usual clinic which comprises 3 monthly doctor reviews and adherence counseling at each review visit.
Other: modified directly administered anti-retroviral therapy (mDAART)
As described before
No Intervention: Control
Participants get usual care at their clinic, which comprises 3 monthly doctor review visits and adherence counseling at each visit.
- Number of Participants with treatment success described as viral load below 1 000 copies/ml at the end of follow-up. [ Time Frame: 3 months ]Participants with viral load >=1 000 copies/ml will be described as treatment failure and proceed to have genotyping for drug resistance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689895
|Beatrice Road Infectious Disease Hospital|
|Harare, Zimbabwe, +263|
|Harare Central Hospital|
|Harare, Zimbabwe, +263|
|Principal Investigator:||Tariro D Chawana, Doctor||University of Zimbabwe|
|Principal Investigator:||Kusum Nathoo, Professor||University of Zimbabwe|
|Principal Investigator:||Charles FB Nhachi, Professor||University of Zimbabwe|