HIV, Low-Birth-Weight Infant, Tuberculosis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
7 Days to 84 Days
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria for Arms 1 and 3 (HIV-exposed infants): * Breastfeeding infants born to HIV-infected mothers who are receiving either no ARV therapy or ARV therapy that does not include NVP * Age 7 to 14 days * Birth weight less than 2500 grams * Receiving or will be receiving prophylaxis as prescribed by clinical care provider as follows: NVP (Arm 1), NVP plus INH (Arm 2), NVP plus INH plus RIF (Arm 3) * Parent or legal guardian able and willing to provide written informed consent. \[Note to sites: modify per locally relevant language\]. Inclusion Criteria for Arm 2 (HIV-exposed infants): * Breastfeeding infants born to HIV-infected mothers who are receiving either no ARV therapy or ARV therapy that does not include NVP * Age 7 to 84 days * Birth weight less than or equal to 4000 grams * Receiving or will be receiving prophylaxis as prescribed by clinical care provider as follows: NVP (Arm 1), NVP plus INH (Arm 2), NVP plus INH plus RIF (Arm 3) * Parent or legal guardian able and willing to provide written informed consent. \[Note to sites: modify per locally relevant language\]. Inclusion Criteria for Arm 4 (HIV-unexposed but TB exposed infants): * Age 7 to 84 days * Birth weight less than or equal to 4000 grams * Receiving prophylaxis with INH alone or INH plus RIF as prescribed by clinical care provider * Not receiving any therapy for HIV prophylaxis or treatment * Parent or legal guardian able and willing to provide written informed consent. \[Note to sites: modify per locally relevant language\]. Inclusion Criteria for Arms 5 and 6 (HIV-infected infants): * Documentation of HIV-1 infection defined as positive HIV DNA PCR done as part of clinical care. An HIV RNA confirmatory test must be done at study entry but results may be pending at time of enrollment. * Birth weight less than or equal to 4000 grams * Age less than or equal to 12 weeks (defined as 84 days) * Intention by clinical care provider to prescribe LPV/r plus 2 NRTIs and no RIF (Arm 5) or LPV/r plus 2 NRTIs plus RIF (Arm 6) * Parent or legally acceptable representative able and willing to provide written informed consent. \[Note to sites: modify per locally relevant language\].
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of NVP, INH, RIF, and LPV/r after oral dose | Week 24 of life | Apparent clearance (CL/F) of NVP, INH, RIF, and LPV/r |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary safety endpoints | Study duration | Number of participants with adverse events of grade 3 or 4 severity, death, or serious adverse clinical events |
Countries
South Africa
Outcome results
None listed