Breastfeeding, Antiretroviral, and Nutrition Study

HIV Infections Clinical Trial

Official title:

HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164736
• Other study ID #: CDC-NCCDPHP-3946
• Secondary ID: U48CCU409660PA 0
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: April 22, 2010
• Start date: March 2004
• Est. completion date: January 2010

Study information

• Verified date: April 2010
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review BoardMalawi: National Health Sciences Research Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2369
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

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

Dietary Supplement:
• Maternal 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.

Locations

Country	Name	City	State
Malawi	Kamuzu Central Hospital, Bottom Hospital	Lilongwe

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Kamuzu Central Hospital, Lilongwe, Malawi, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum weight loss between delivery and 28 weeks		between delivery and 28 weeks	Yes
Primary	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	No
Primary	Exclusive breastfeeding and breastfeeding cessation by 28 weeks		birth to 28 weeks	No
Secondary	Duration of exclusive breastfeeding		birth to 28 weeks	No
Secondary	Infant HIV status through 48 weeks		birth to 48 weeks	No
Secondary	Maternal adherence to ARV, maternal CD4 count, and clinical assessment of opportunistic infection status through 48 weeks		delivery to 48 weeks	No