Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Breastfeeding, Antiretroviral, and Nutrition Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00164736
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 23, 2010
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
Kamuzu Central Hospital
Information provided by:
Centers for Disease Control and Prevention

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date April 23, 2010
Study Start Date  ICMJE March 2004
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2008)
  • Postpartum weight loss between delivery and 28 weeks [ Time Frame: between delivery and 28 weeks ]
  • 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 ]
  • Exclusive breastfeeding and breastfeeding cessation by 28 weeks [ Time Frame: birth to 28 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • 1. Postpartum weight loss between delivery and 28 weeks.
  • 2. Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.)
  • 3. Exclusive breastfeeding and breastfeeding cessation by 28 weeks.
Change History Complete list of historical versions of study NCT00164736 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2008)
  • Duration of exclusive breastfeeding [ Time Frame: birth to 28 weeks ]
  • Infant HIV status through 48 weeks [ Time Frame: birth to 48 weeks ]
  • Maternal adherence to ARV, maternal CD4 count, and clinical assessment of opportunistic infection status through 48 weeks [ Time Frame: delivery to 48 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • 1. Duration of exclusive breastfeeding;
  • 2. Infant HIV status through 48 weeks;
  • 3. Maternal adherence to ARV, maternal CD4 count, and clinical assessment of opportunistic infection status through 48 weeks.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Breastfeeding, Antiretroviral, and Nutrition Study
Official Title  ICMJE HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health
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.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • 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.
    Other Names:
    • Combivir tabs (zidovudine 300mg and lamivudine 150mg)
    • Aluvia tabs (lopinavir 200mg /ritonavir 50mg)
  • Drug: Infant nevirapine

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

    To 28 weeks while breastfeeding.

    Other Name: Viramune (Nevirapine) suspension 50mg/5ml
  • 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.
    Other Name: Produced by Nutriset. Daily dose: 2 sachets.
Study Arms
  • Active Comparator: Maternal ARVs & Nutrition Supplement
    Extended maternal ARVs for prophylaxis (for the infant) & daily nutritional supplement given to the mother
    Interventions:
    • Drug: Maternal zidovudine/lamivudine/lopinavir-ritonavir
    • Dietary Supplement: Maternal protein and calorie supplement
  • Active Comparator: Infant NVP & Nutrition Supplement
    Extended infant nevirapine for prophylaxis & daily nutritional supplment given to the mother
    Interventions:
    • Drug: Infant nevirapine
    • Dietary Supplement: Maternal protein and calorie supplement
  • Active Comparator: Maternal ARVs & No Nutrition Supplement
    Extended maternal ARVs for prophylaxis (for the infant) & no nutritional supplement given to the mother
    Intervention: Drug: Maternal zidovudine/lamivudine/lopinavir-ritonavir
  • Active Comparator: Infant NVP & No Nutrition Supplement
    Extended infant nevirapine for prophylaxis & no nutritional supplment given to the mother
    Intervention: Drug: Infant nevirapine
  • Active Comparator: No Drugs & Nutrition Supplement

    No extended maternal ARV prophylaxis nor infant nevirapine prophylaxis & daily nutritional supplement given to the mother.

    Note: As of March 2008, the third arm of the antiretroviral intervention, in which neither mother nor infant received drugs beyond enhanced standard of care, was stopped based on recommendations of a Data and Safety Monitoring Board review of interim efficacy results and safety data after 77% participants had received treatment assignment.

    Intervention: Dietary Supplement: Maternal protein and calorie supplement
  • No Intervention: No Drugs & No Nutrition Supplement

    No extended maternal ARV prophylaxis nor infant nevirapine prophylaxis & no nutritional supplement given to the mother.

    Note: As of March 2008, the third arm of the antiretroviral intervention, in which neither mother nor infant received drugs beyond enhanced standard of care, was stopped based on recommendations of a Data and Safety Monitoring Board review of interim efficacy results and safety data after 77% participants had received treatment assignment.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2010)
2369
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
2418
Actual Study Completion Date January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00164736
Other Study ID Numbers  ICMJE CDC-NCCDPHP-3946
U48CCU409660 ( Other Grant/Funding Number: U.S. Centers for Disease Control and Prevention )
PA 04003 SIP 26-04 ( Other Grant/Funding Number: U.S. Centers for Disease Control and Prevention )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Denise Jamieson, CDC
Study Sponsor  ICMJE Centers for Disease Control and Prevention
Collaborators  ICMJE
  • University of North Carolina, Chapel Hill
  • Kamuzu Central Hospital
Investigators  ICMJE
Study Chair: Charles van der Horst, MD 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
PRS Account Centers for Disease Control and Prevention
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP