Low-Birth-Weight InfantNCT02383849

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

An observational study of Low-Birth-Weight Infant and Tuberculosis, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 2 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 7 to 84 days
Conditions the study is for: Low-Birth-Weight Infant, Tuberculosis, HIV
How many people: 124 participants
Where: 2 sitesSouth Africa
Study dates: 4 Aug 2015to 14 Feb 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 84 days
All sexes
No healthy volunteers
Child

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)

Who may be able to join

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].
Breastfeeding infants born to HIV-infected mothers who are receiving either no ARV therapy or ARV therapy that does not include NVP

Show all 21Show fewer

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].
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].

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

Family Clinical Research Unit (FAM-CRU) CRS (8950)
Cape Town, Western Cape, 7505
Soweto IMPAACT CRS (8052)
Johannesburg, Gauteng, 1862

Other trials in South Africa

About this study

Conditions: Low-Birth-Weight Infant, Tuberculosis, HIV
Medical subject headings: Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02383849
Study group	Role	What they receive
Arm 1		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
Arm 2		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
Arm 3		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
Arm 4		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
Arm 5		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)
Arm 6		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)

What is being measured

The primary outcome is the main question the study is designed to answer.

Clearance of NVP, INH, RIF, and LPV/r after oral dose
Apparent clearance (CL/F) of NVP, INH, RIF, and LPV/r
Measured: Week 24 of life

Secondary outcomes (1)

Primary safety endpoints
Number of participants with adverse events of grade 3 or 4 severity, death, or serious adverse clinical events
Measured: Study duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 201514 Feb 2020

First posted9 Mar 2015 (estimated)
Study start4 Aug 2015
Primary completion14 Feb 2020
Study completion14 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low-Birth-Weight InfantStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02383849
Sponsor's protocol ID: IMPAACT P1106
Other IDs: 11882
Status last verified: Mar 2020
First submitted: 22 Oct 2014
Last updated: 6 Aug 2021
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes: Individual participant data that underlie results in the publication, after deidentification.

Publications

Bekker A, Yang J, Wang J, Cotton MF, Cababasay M, Wiesner L, Moye J, Browning R, Nakwa FL, Rabie H, Violari A, Mirochnick M, Cressey TR, Capparelli EV. Safety and Pharmacokinetics of Lopinavir/Ritonavir Oral Solution in Preterm and Term Infants Starting Before 3 Months of Age. Pediatr Infect Dis J. 2024 Apr 1;43(4):355-360. doi: 10.1097/INF.0000000000004243. Epub 2024 Jan 4.
PubMed 38190642

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants
Intervention
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
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RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
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Not yet recruitingPhase 1
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Breast-milk

All Low-Birth-Weight Infant trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IMPAACT P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants
ClinicalTrials.gov ID: NCT02383849
Acronym / sponsor ID: IMPAACT P1106
Conditions: Low-Birth-Weight Infant, Tuberculosis, HIV
Study type: Observational
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 4 Aug 2015 (actual)
Primary completion: 14 Feb 2020 (actual)
Study completion: 14 Feb 2020 (actual)
First posted: 9 Mar 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 6

Arm	Type	Receives
Arm 1	–	–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
Arm 2	–	–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
Arm 3	–	–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
Arm 4	–	–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
Arm 5	–	–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)
Arm 6	–	–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)

Who may qualify

Ages: 7 to 84 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
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)

Key inclusion criteria (21 listed)

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].

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Clearance of NVP, INH, RIF, and LPV/r after oral dose
Time frame: Week 24 of life
Apparent clearance (CL/F) of NVP, INH, RIF, and LPV/r

1 secondary outcome

Primary safety endpoints
Time frame: Study duration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
Derived from this study: PubMed 38190642Bekker A, Yang J, Wang J, Cotton MF, Cababasay M, Wiesner L, Moye J, Browning R, Nakwa FL, Rabie H, Violari A, Mirochnick M, Cressey TR, Capparelli EV. Safety and Pharmacokinetics of Lopinavir/Ritonavir Oral Solution in Preterm and Term Infants Starting Before 3 Months of Age. Pediatr Infect Dis J. 2024 Apr 1;43(4):355-360. doi: 10.1097/INF.0000000000004243. Epub 2024 Jan 4.
Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.

Related trials for Low-Birth-Weight Infant

Recruiting
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants
Intervention
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Not yet recruitingPhase 1
Breast-milk Enema Administration to Stimulate Passage of Meconium
Breast-milk

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Cotton, MD, MBChB, FCPaed, MMED study chair

University of Stellenbosch

Mark H Mirochnick, MD study chair

Boston Medical Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Low-Birth-Weight Infant and Tuberculosis, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 2 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clearance of NVP, INH, RIF, and LPV/r after oral dose (time frame: Week 24 of life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02383849, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.