Tuberculosis Clinical Trial
Official title:
A Pharmacokinetics Study Comparing Lopinavir Plasma Exposure When Given as Lopinavir/Ritonavir (1:1) in the Presence of Rifampicin and Lopinavir/Ritonavir (4:1) Without Rifampicin in HIV and TB Co-infected Children in South Africa.
Verified date | May 2017 |
Source | Drugs for Neglected Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the lopinavir levels in blood of HIV and TB infected children (3-15kg) when given lopinavir/ritonavir in a 1:1 ratio with rifampicin containing TB regimen and its safety.
Status | Completed |
Enrollment | 96 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Documentation of a confirmed diagnosis of HIV-1 infection following SA clinical guidelines - Weight >3kg =15 kg at enrolment - > 42 weeks gestational age - On LPV/r-based therapy or about to start a LPV/r-based antiretroviral combination therapy with 2 NRTIs [ABC+3TC or AZT+3TC or d4T+3TC] - Clinical diagnosis of TB requiring RIF-based therapy - Parent or legal guardian able and willing to provide written informed consent and able to attend study visits. Exclusion Criteria: - For neonates, less than 42 weeks gestation and 14 days old - Concomitant/chronic treatment with potent enzyme-inducing/inhibiting drugs other than those in the study treatments . See Appendix E (minor inducers/inhibitors and drugs used as part of management of the condition are allowed eg. Steroids) - Anticipation at the start that anti-TB treatment duration will be longer than 9 months - Any other condition/finding that, in the investigator's opinion, would compromise the child's participation in this study eg. alanine transferase (ALT) more than 10 times upper limit of normal (ULN), or chronic renal, hepatic or gastrointestinal disease such as malabsorption. - Children with known malignancies and contraindications to taking LPV/r - Treatment with experimental drugs for any indication within 30 days prior to study entry; participation in another study may be approved by the study team. |
Country | Name | City | State |
---|---|---|---|
South Africa | The Children's Infectious Disease Clinical Research Unit; University of Stellenbosch | Cape Town | Western Cape |
South Africa | Enhancing Care Foundation; Wendworth Hospital | Durban | |
South Africa | Empilweni Services and Research Unit | Johannesburg | |
South Africa | Perinatal HIV Research Unit | Johannesburg | |
South Africa | Shandukani Research WRHI | Johannesburg |
Lead Sponsor | Collaborator |
---|---|
Drugs for Neglected Diseases | French Development Agency, Medecins Sans Frontieres, Netherlands, UBS Optimus Foundation, University of Cape Town |
South Africa,
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* Note: There are 46 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modelled C0/morning trough | Proportions of children treated with modelled lopinavir morning C0/morning trough <1mg/L at each of the intensive PK evaluations. | Predose | |
Secondary | C0/morning trough | Proportions of children with observed lopinavir morning trough, C0/morning trough <1mg/L at each of the intensive PK evaluations | Predose | |
Secondary | ALT | Safety and tolerability of superboosting focusing on liver functions through clinical and biochemical monitoring. | baseline, PK1, PK2, PK3 | |
Secondary | ECG | Potential superboosting cardiac effect monitored by electrocardiogram at the beginning of anti-TB and HIV concomitant therapy | baseline, 2 weeks after LPV/r 1:1, PK1 |
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