IMPAACT P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants

HIV Clinical Trial

Official title:

IMPAACT P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383849
• Other study ID #: IMPAACT P1106
• Secondary ID: 11882
• Status: Completed
• Start date: August 4, 2015
• Est. completion date: February 14, 2020

Study information

• Verified date: March 2020
• Source: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 14, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 84 Days

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• HIV
• Low-Birth-Weight Infant
• Tuberculosis

Locations

Country	Name	City	State
South Africa	Family Clinical Research Unit (FAM-CRU) CRS (8950)	Cape Town	Western Cape Province
South Africa	Soweto IMPAACT CRS (8052)	Johannesburg	Gauteng

Sponsors (3)

Lead Sponsor	Collaborator
International Maternal Pediatric Adolescent AIDS Clinical Trials Group	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance of NVP, INH, RIF, and LPV/r after oral dose	Apparent clearance (CL/F) of NVP, INH, RIF, and LPV/r	Week 24 of life
Secondary	Primary safety endpoints	Number of participants with adverse events of grade 3 or 4 severity, death, or serious adverse clinical events	Study duration