Breastfeeding, Antiretroviral, and Nutrition Study - Full Text View

Sponsor:	Centers for Disease Control and Prevention
Collaborators:	The University of North Carolina, Chapel Hill Kamuzu Central Hospital, Lilongwe, Malawi
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00164736

Purpose

This is a comparative clinical trial among HIV-infected women and their infants to determine:

the benefit of nutritional supplementation given to women during breastfeeding
the benefit and safety of antiretroviral (ARV) medications given either to infants or to their mothers to prevent HIV transmission during breastfeeding
the feasibility of exclusive breastfeeding followed by early, rapid breastfeeding cessation

Condition	Intervention	Phase
HIV Infections	Drug: Maternal zidovudine/lamivudine/lopinavir-ritonavir Drug: Infant nevirapine Dietary Supplement: Maternal protein and calorie supplement	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health

Resource links provided by NLM:

MedlinePlus related topics: AIDS Breast Feeding Dietary Supplements

Drug Information available for: Zidovudine Nevirapine Lamivudine Ritonavir Combivir Lopinavir

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

Postpartum weight loss between delivery and 28 weeks [ Time Frame: between delivery and 28 weeks ] [ Designated as safety issue: Yes ]
Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.) [ Time Frame: birth to 28 weeks ] [ Designated as safety issue: No ]
Exclusive breastfeeding and breastfeeding cessation by 28 weeks [ Time Frame: birth to 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of exclusive breastfeeding [ Time Frame: birth to 28 weeks ] [ Designated as safety issue: No ]
Infant HIV status through 48 weeks [ Time Frame: birth to 48 weeks ] [ Designated as safety issue: No ]
Maternal adherence to ARV, maternal CD4 count, and clinical assessment of opportunistic infection status through 48 weeks [ Time Frame: delivery to 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	2370
Study Start Date:	March 2004
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1A: Active Comparator	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. 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.
1B: Active Comparator	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.
2A: Active Comparator	Drug: 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.
2B: Active Comparator	Drug: Infant nevirapine Nevirapine suspension once daily dose. 0-14days: 10mg; 3-18weeks: 20mg; 19-28weeks: 30mg. To 28 weeks while breastfeeding.

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:

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).
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.
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.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164736

Locations

Malawi
Kamuzu Central Hospital, Bottom Hospital
Lilongwe, Malawi

Sponsors and Collaborators

Centers for Disease Control and Prevention

The University of North Carolina, Chapel Hill

Kamuzu Central Hospital, Lilongwe, Malawi

Investigators

Study Chair:	Charles van der Horst, MD	The University of North Carolina, Chapel Hill
Principal Investigator:	Denise J Jamieson, MD, MPH	CDC, Atlanta, GA
Principal Investigator:	Peter Kazembe, MB ChB	Kamuzu Central Hospital, Lilongwe, Malawi

More Information

No publications provided

Responsible Party:	CDC ( Dr. Denise Jamieson )
Study ID Numbers:	CDC-NCCDPHP-3946, U48CCU409660, PA 04003 SIP 26-04
Study First Received:	September 13, 2005
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00164736 History of Changes
Health Authority:	United States: Federal Government; United States: Institutional Review Board; Malawi: National Health Sciences Research Committee

Keywords provided by Centers for Disease Control and Prevention:

HIV
Clinical trial
breastfeeding

mother-to-child-transmission
nutrition
HIV Seronegativity

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Lopinavir
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Nevirapine
HIV Infections
Ritonavir
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on February 08, 2010