An observational study in Low-Birth-Weight Infant, Tuberculosis and HIV, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group. Completed at 2 sites in South Africa. Open to participants aged 7 Days to 84 Days. Per ClinicalTrials.gov, last updated 2021-08-06.
Sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Observational
P1106 is Phase IV prospective pharmacokinetic (PK) study of low birth weight infants who are receiving or will be receiving as part of clinical care nevirapine (NVP) prophylaxis, tuberculosis (TB) prophylaxis or treatment and/or combination antiretroviral (ARV) treatment containing lopinavir/ritonavir (LPV/r). The study is designed to describe the pharmacokinetics and safety of NVP, INH, RIF, and LPV/r in these infants receiving the drug(s) as part of clinical care.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 124 is below the median of 250 across 421 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →International Maternal Pediatric Adolescent AIDS Clinical Trials Group is the lead sponsor of 26 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Low birth weight (LBW) infants less than or equal to 2500 grams at birth who are receiving or will be receiving as part of clinical care nevirapine (NVP) prophylaxis, tuberculosis (TB) prophylaxis or treatment and/or combination antiretroviral (ARV) treatment containing lopinavir/ritonavir (LPV/r)
Inclusion Criteria for Arms 1 and 3 (HIV-exposed infants):
Inclusion Criteria for Arm 2 (HIV-exposed infants):
Inclusion Criteria for Arm 4 (HIV-unexposed but TB exposed infants):
Inclusion Criteria for Arms 5 and 6 (HIV-infected infants):
Exclusion Criteria:
Any severe congenital malformation or other medical condition incompatible with life or that would interfere with study participation or interpretation, as judged by the examining clinician.
Breastfeeding infants 7 to 14 days of age with birth weight less than 2500 grams born to HIV-infected mothers not receiving maintenance ARV therapy including NVP; Mother HIV-infected and TB negative; infant receiving NVP prophylaxis but not TB prophylaxis or treatment
Breastfeeding infants 7 to 84 days of age with birth weight less than or equal to 4000 grams born to HIV-infected mothers not receiving maintenance ARV therapy including NVP; Mother HIV-infected with active TB disease; infant receiving NVP prophylaxis plus isoniazid (INH) but not rifampicin (RIF) for TB prophylaxis
Breastfeeding infants 7 to 14 days of age with birth weight less than 2500 grams born to HIV-infected mothers not receiving maintenance ARV therapy including NVP; Mother HIV-infected with active TB disease; infant receiving NVP prophylaxis plus INH plus RIF for TB prophylaxis or treatment
Breast or formula feeding infants 7 to 84 days of age with birth weight less than or equal to 4000 grams born to HIV-uninfected mothers with active TB disease; infant receiving INH alone or INH plus RIF for TB prophylaxis
Breast or formula feeding infants newly diagnosed with HIV infection weighing less than or equal to 4000 grams at birth and are less than or equal to 12 weeks of age. Infants who were enrolled in Arms 1, 2 or 3 and later determined to be HIV infected are then are eligible to enroll in Arm 5 if started on an LPV/r regimen. Infants initiating treatment with LPV/r plus 2 NRTIs, and not receiving RIF (but may be receiving INH)
Breast or formula feeding infants newly diagnosed with HIV infection weighing less than 2500 grams at birth and are less than or equal to 12 weeks of age. Infants who were enrolled in Arms 1, 2 or 3 and later determined to be HIV infected are then are eligible to enroll in Arm 6 if started on an LPV/r regimen. Infants initiating treatment with LPV/r plus 2 NRTIs, and receiving RIF (and may be receiving INH)
Clearance of NVP, INH, RIF, and LPV/r after oral dose
Apparent clearance (CL/F) of NVP, INH, RIF, and LPV/r
Time frame: Week 24 of life
Primary safety endpoints
Number of participants with adverse events of grade 3 or 4 severity, death, or serious adverse clinical events
Time frame: Study duration
Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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International Maternal Pediatric Adolescent AIDS Clinical Trials Group