Aetiology of treatment failure in HIV positive children and adolescents on boosted protease inhibitor based regimens.

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201502001028169
• Date of registration: 04/02/2015
• Prospective Registration: No
• Public title: Aetiology of treatment failure in HIV positive children and adolescents on boosted protease inhibitor based regimens.
• Scientific title: Aetiology of treatment failure in HIV positive children and adolescents on boosted protease inhibitor based regimens.
• Date of first enrolment: 01/07/2014
• Target sample size: 130
• Recruitment status: Recruiting
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1028
• Study type: Interventional
• Study design: Single group: all participants receive same intervention throughout study,Randomised,Simple randomisation by using a randomisation table created by a computer software program.,Sealed opaque envelopes
• Phase: Not Applicable

Countries of recruitment

Zimbabwe

Contacts

• Name: Tariro Chawana
• Affiliation: DPhil student

• Name: Tariro Chawana
• Affiliation: DPhil student

Key inclusion & exclusion criteria

Inclusion criteria: 1. Parents/guardian willing to consent
2. Child willing to provide assent
3. Documented HIV positive antibody or antigen test
4. Child knows their HIV status
5. Aged between 6 and 16 years (that is, from the day of their sixth birthday up to the eve of their seventeenth birthday)
6. Registered at Harare hospital paediatric opportunistic infections clinic
7. On second line treatment (ATV/r based)
8. Have taken the above named second line treatment for at least 6 complete, consecutive months
9. Has virological and immunological treatment failure as defined by WHO 2012 criteria
Exclusion criteria: 1. Patients registered at other health centres who have been referred for specialist care at Harare hospital paediatric opportunistic infections clinic
2. On ATV/r as first line treatment
3. Patients who do not want to be followed up at home.

Age minimum: 6 Year(s)
Age maximum: 18 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS

HIV/AIDS

Intervention(s)

Self administered therapy (SAT)

Directly administered antiretroviral therapy (DAART)

Primary Outcome(s)

Virological failure

Secondary Outcome(s)

Atazanavir concentration in hair

Source(s) of Monetary Support

Fogarty International Center

Secondary Sponsor(s)

University of Zimbabwe

Ethics review

Status: Approved
Approval date: 31/07/2014
Contact:

Medical Reseach Council of Zimbabwe