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

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.