Clinical trial NCT02383849: IMPAACT P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants
Official title: IMPAACT P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low-Birth-Weight Infant
Tuberculosis
HIV
Lead sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-03-09
Enrollment: 124
Sex: ALL
Minimum age (years): 7
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clearance of NVP, INH, RIF, and LPV/r after oral dose
timeFrame: Week 24 of life
Secondary outcomes:
measure: Primary safety endpoints
timeFrame: Study duration
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Soweto IMPAACT CRS (8052)
state: Gauteng
city: Cape Town
country: South Africa
facility: Family Clinical Research Unit (FAM-CRU) CRS (8950)
state: Western Cape Province
Study officials:
affiliation: University of Stellenbosch
name: Mark Cotton, MD, MBChB, FCPaed, MMED
role: STUDY_CHAIR
affiliation: Boston Medical Center
name: Mark H Mirochnick, MD
role: STUDY_CHAIR
References: