Breastfeeding, Antiretroviral, and Nutrition Study

Conditions

HIV Infections

Keywords

HIV, Clinical trial, breastfeeding, mother-to-child-transmission, nutrition, HIV Seronegativity

Brief summary

This is a comparative clinical trial among HIV-infected women and their infants to determine: 1. the benefit of nutritional supplementation given to women during breastfeeding 2. the benefit and safety of antiretroviral (ARV) medications given either to infants or to their mothers to prevent HIV transmission during breastfeeding 3. the feasibility of exclusive breastfeeding followed by early, rapid breastfeeding cessation

Detailed description

This study addresses the complex issues of HIV related maternal morbidity, mortality, and postnatal HIV transmission during breastfeeding and weaning in resource-poor countries. Objectives include assessment of mortality and morbidity among HIV-infected women; evaluation of interventions to reduce HIV transmission to infants exposed by breast milk; and assessment of early weaning as a risk-reduction strategy for infants of HIV-infected mothers. The study will evaluate the following: 1. The efficacy of a high-density caloric/micronutrient nutritional supplement given to HIV-infected women who breastfeed in preventing maternal depletion (weight loss and micronutrient status). 2. The safety and efficacy of maternal or infant antiretroviral regimens, taken for up to 6 months during breastfeeding, in reducing infant HIV infection rates at 48 weeks. 3. The feasibility of exclusive breastfeeding for 6 months followed by rapid weaning. Additional study objectives are to evaluate the feasibility of delivering these interventions in resource poor settings and to identify maternal, infant, and virologic factors associated with HIV transmission during breastfeeding.

Elizabeth M. Widen, Margaret E. Bentley, Dumbani Kayira, Charles Chasela, Eric J. Daza et al. (13 authors)

UNC Libraries2020-11-09

10.17615/sgjm-cz36

Plasma Micronutrient Concentrations Are Altered by Antiretroviral Therapy and Lipid-Based Nutrient Supplements in Lactating HIV-Infected Malawian Women.

Flax VL, Adair LS, Allen LH, Shahab-Ferdows S, Hampel D, Chasela CS, Tegha G, Daza EJ, Corbett A, Davis NL, Kamwendo D, Kourtis AP, van der Horst CM, Jamieson DJ, Bentley ME, BAN Study Team.

2015-07-0811 citations

10.3945/jn.115.212290

Changes in soluble transferrin receptor and hemoglobin concentrations in Malawian mothers are associated with those values in their exclusively breastfed, HIV-exposed infants.

Widen EM, Bentley ME, Kayira D, Chasela CS, Daza EJ, Kacheche ZK, Tegha G, Jamieson DJ, Kourtis AP, van der Horst CM, Allen LH, Shahab-Ferdows S, Adair LS, BAN Study Team.

2013-12-314 citations

10.3945/jn.113.177915

Maternal and infant antiretroviral regimens to prevent postnatal HIV-1 transmission: 48-week follow-up of the BAN randomised controlled trial.

Jamieson DJ, Chasela CS, Hudgens MG, King CC, Kourtis AP, Kayira D, Hosseinipour MC, Kamwendo DD, Ellington SR, Wiener JB, Fiscus SA, Tegha G, Mofolo IA, Sichali DS, Adair LS, Knight RJ, Martinson F, Kacheche Z, Soko A, Hoffman I, van der Horst C, BAN study team.

2012-04-2665 citations

10.1016/s0140-6736(12)60321-3

Maternal or infant antiretroviral drugs to reduce HIV-1 transmission.

Chasela CS, Hudgens MG, Jamieson DJ, Kayira D, Hosseinipour MC, Kourtis AP, Martinson F, Tegha G, Knight RJ, Ahmed YI, Kamwendo DD, Hoffman IF, Ellington SR, Kacheche Z, Soko A, Wiener JB, Fiscus SA, Kazembe P, Mofolo IA, Chigwenembe M, Sichali DS, van der Horst CM, BAN Study Group.

2010-06-01314 citations

10.1056/nejmoa0911486

Interventions

DRUGMaternal zidovudine/lamivudine/lopinavir-ritonavir

Total daily dose: zidovudine 600mg, lamivudine 300mg, (taken as Combivir 1 tab twice a day with food). Lopinavir/ritonavir 400/100mg (taken as 2 tabs twice a day). Commencing after delivery and through to 28 weeks.

DRUGInfant nevirapine

Nevirapine suspension once daily dose. 0-14days: 10mg; 3-18weeks: 20mg; 19-28weeks: 30mg. To 28 weeks while breastfeeding.

DIETARY_SUPPLEMENTMaternal protein and calorie supplement

High energy, nutrient-dense, micronutrient fortified nutritional supplement. Daily: Energy 700kcal, Protein 20g, 100% of recommended dietary allowance for all micronutrients during the 6 months of lactation. Vitamin A is excluded.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Recruitment and primary eligibility criteria: * Age \> 14 years. * Ability to give informed assent or consent. * Evidence of HIV infection, as documented by 2 positive ELISA antibody tests; or 1 positive ELISA, and 1 Western Blot; or 2 separate concurrent rapid tests. * Currently pregnant (with a single or multiple fetuses). * Gestation \< 30 weeks at referral from 'Call to Action' Program * No serious current complications of pregnancy. * Intention to breastfeed. * Intention to deliver at the institution at which the study is based. * Not previously enrolled in this study for an earlier pregnancy. * Other than HIV, no active serious infection, such as tuberculosis or other potentially serious illnesses. * No previous use of antiretrovirals including the HIVNET 012 regimen. * Mother's CD4 count \> 250 cells/uL determined in the antenatal clinic. * Mother's ALT \< 2.5 x ULN (upper limit of normal) determined in the antenatal clinic Secondary eligibility criteria and treatment assignment: * Mother who delivers outside of the institution at which the study is based must present with her infant to the study site within 36 hours of delivery. * Mother accepts nevirapine and zidovudine+lamivudine 7-day regimen for herself and her infant. * Infant birth weight \> 2000 g. * No severe congenital malformations or other condition(s) not compatible with life. * Based on clinical assessment, no maternal condition which would preclude the start of the study intervention.

Design outcomes

Primary

Measure	Time frame
Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.)	birth to 28 weeks
Postpartum weight loss between delivery and 28 weeks	between delivery and 28 weeks
Exclusive breastfeeding and breastfeeding cessation by 28 weeks	birth to 28 weeks

Secondary

Measure	Time frame
Duration of exclusive breastfeeding	birth to 28 weeks
Infant HIV status through 48 weeks	birth to 48 weeks
Maternal adherence to ARV, maternal CD4 count, and clinical assessment of opportunistic infection status through 48 weeks	delivery to 48 weeks

Countries

Malawi

Outcome results

None listed