Children with HIV in Africa – pharmacokinetics and acceptability of simple second-line antiretroviral regimens
- Conditions
- HIV infectionInfections and InfestationsHuman immunodeficiency virus [HIV] disease
- Registration Number
- ISRCTN22964075
- Lead Sponsor
- niversity College London (UK)
- Brief Summary
2023 Interim results article in https://pubmed.ncbi.nlm.nih.gov/37280040/ Pharmacokinetic substudy secondary outcome results (added 07/06/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37315296/ Substudy results (added 15/06/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37471330/ Substudy results (added 21/07/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 919
Current inclusion criteria as of 17/07/2019:
1. HIV-infected currently receiving NNRTI containing regimen with abacavir-, zidovudine- or stavudine-containing NRTIbackbone and failing according to current WHO criteria:
1.1. Confirmed VL >1000 copies/ml after adherence counselling (confirmatory may be at screening) OR
1.2. CD4 criteria for failure OR
1.3. Clinical criteria for failure
2. Aged 3-15 years inclusive
3. Weight 14 kg or higher
4. Viral load >400 copies/ml at screening visit
5. Able to swallow trial drug tablets (all children will have been receiving tablets within first-line ART)
6. If female and reached menses, then negative pregnancy test at screening (and randomisation if randomisation >2 weeks from screening) and willing to adhere to highly effective methods of contraception if sexually active
7. Parents/carers give informed written consent; child provides informed written assent as appropriate based on age, knowledge of HIV status and local country guidelines
Previous inclusion criteria:
1. HIV-infected failing first-line treatment with abacavir-, zidovudine- or stavudine-containing NRTI+NNRTI regimens as per current WHO criteria
2. Aged 3-15 years inclusive
3. Weight 14 kg or higher
4. Viral load >400 copies/ml at screening visit
5. Able to swallow trial drug tablets (all children will have been receiving tablets within first-line ART)
6. Parents/carers give informed written consent; child provides informed written assent as appropriate based on age, knowledge of HIV status and local country guidelines
Current exclusion criteria as of 17/07/2019:
1. History or presence of known allergy or other contraindication to the study drugs or their components
2. Treatment of co-morbidities, except TB, with significant drug interactions with the study drugs, requiring their dose adjustment
3. Breastfeeding
4. More than 3 months (>91 days) from the screening visit
5. Evidence of previous failure on LPV/r
6. Evidence of previous failure on both abacavir and zidovudine
7. Alanine aminotransferase (ALT) =5 times the upper limit of normal (ULN), OR ALT =3xULN and bilirubin =2xULN
8. Patients with severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Previous exclusion criteria:
1. History or presence of known allergy or other contraindication to the study drugs or their components
2. Treatment of co-morbidities, except TB, with significant drug interactions with the study drugs, requiring their dose adjustment
3. More than 3 months (>91 days) from the screening visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of children alive with viral load <400 copies/ml, measured with lab test at baseline and weeks 6, 24, 48, 72, 96
- Secondary Outcome Measures
Name Time Method