Back to results

Breastfeeding, Antiretroviral, and Nutrition Study

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 3

Locations

Malawi

Study Type

Interventional

Intervention

Maternal zidovudine/lamivudine/lopinavir-ritonavir

Infant nevirapine

Maternal protein and calorie supplement

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, Clinical trial, breastfeeding, mother-to-child-transmission, nutrition, HIV Seronegativity

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Kamuzu Central Hospital, Bottom Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

No Intervention

Arm Label

Maternal ARVs & Nutrition Supplement

Infant NVP & Nutrition Supplement

Maternal ARVs & No Nutrition Supplement

Infant NVP & No Nutrition Supplement

No Drugs & Nutrition Supplement

No Drugs & No Nutrition Supplement

Arm Description

Extended maternal ARVs for prophylaxis (for the infant) & daily nutritional supplement given to the mother

Extended infant nevirapine for prophylaxis & daily nutritional supplment given to the mother

Extended maternal ARVs for prophylaxis (for the infant) & no nutritional supplement given to the mother

Extended infant nevirapine for prophylaxis & no nutritional supplment given to the mother

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.

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.

Outcomes

Primary Outcome Measures

Postpartum weight loss 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.)

Exclusive breastfeeding and breastfeeding cessation by 28 weeks

Secondary Outcome Measures

Duration of exclusive breastfeeding

Infant HIV status through 48 weeks

Maternal adherence to ARV, maternal CD4 count, and clinical assessment of opportunistic infection status through 48 weeks

Full Information

NCT ID

NCT00164736

First Posted

September 13, 2005

Last Updated

April 22, 2010

Sponsor

Centers for Disease Control and Prevention

Collaborators

University of North Carolina, Chapel Hill, Kamuzu Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00164736

Brief Title

Breastfeeding, Antiretroviral, and Nutrition Study

Official Title

HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Centers for Disease Control and Prevention

Collaborators

University of North Carolina, Chapel Hill, Kamuzu Central Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2369 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Maternal ARVs & Nutrition Supplement

Arm Type

Active Comparator

Arm Description

Extended maternal ARVs for prophylaxis (for the infant) & daily nutritional supplement given to the mother

Arm Title

Infant NVP & Nutrition Supplement

Arm Type

Active Comparator

Arm Description

Extended infant nevirapine for prophylaxis & daily nutritional supplment given to the mother

Arm Title

Maternal ARVs & No Nutrition Supplement

Arm Type

Active Comparator

Arm Description

Extended maternal ARVs for prophylaxis (for the infant) & no nutritional supplement given to the mother

Arm Title

Infant NVP & No Nutrition Supplement

Arm Type

Active Comparator

Arm Description

Extended infant nevirapine for prophylaxis & no nutritional supplment given to the mother

Arm Title

No Drugs & Nutrition Supplement

Arm Type

Active Comparator

Arm Description

Arm Title

No Drugs & No Nutrition Supplement

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Maternal zidovudine/lamivudine/lopinavir-ritonavir

Other Intervention Name(s)

Combivir tabs (zidovudine 300mg and lamivudine 150mg), Aluvia tabs (lopinavir 200mg /ritonavir 50mg)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Infant nevirapine

Other Intervention Name(s)

Viramune (Nevirapine) suspension 50mg/5ml

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Maternal protein and calorie supplement

Other Intervention Name(s)

Produced by Nutriset. Daily dose: 2 sachets.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Postpartum weight loss between delivery and 28 weeks

Time Frame

between delivery and 28 weeks

Title

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

Title

Exclusive breastfeeding and breastfeeding cessation by 28 weeks

Time Frame

birth to 28 weeks

Secondary Outcome Measure Information:

Title

Duration of exclusive breastfeeding

Time Frame

birth to 28 weeks

Title

Infant HIV status through 48 weeks

Time Frame

birth to 48 weeks

Title

Maternal adherence to ARV, maternal CD4 count, and clinical assessment of opportunistic infection status through 48 weeks

Time Frame

delivery to 48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles van der Horst, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Denise J Jamieson, MD, MPH

Organizational Affiliation

CDC, Atlanta, GA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Peter Kazembe, MB ChB

Organizational Affiliation

Kamuzu Central Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kamuzu Central Hospital, Bottom Hospital

City

Lilongwe

Country

Malawi

12. IPD Sharing Statement

Citations:

PubMed Identifier

26156797

Citation

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. Plasma Micronutrient Concentrations Are Altered by Antiretroviral Therapy and Lipid-Based Nutrient Supplements in Lactating HIV-Infected Malawian Women. J Nutr. 2015 Aug;145(8):1950-7. doi: 10.3945/jn.115.212290. Epub 2015 Jul 8.

Results Reference

derived

PubMed Identifier

25723140

Citation

Widen EM, Bentley ME, Chasela CS, Kayira D, Flax VL, Kourtis AP, Ellington SR, Kacheche Z, Tegha G, Jamieson DJ, van der Horst CM, Allen LH, Shahab-Ferdows S, Adair LS; BAN Study Team. Antiretroviral Treatment Is Associated With Iron Deficiency in HIV-Infected Malawian Women That Is Mitigated With Supplementation, but Is Not Associated With Infant Iron Deficiency During 24 Weeks of Exclusive Breastfeeding. J Acquir Immune Defic Syndr. 2015 Jul 1;69(3):319-28. doi: 10.1097/QAI.0000000000000588. Erratum In: J Acquir Immune Defic Syndr. 2015 Aug 15;69(5):e184.

Results Reference

derived

PubMed Identifier

24500152

Citation

Flax VL, Bentley ME, Combs GF Jr, Chasela CS, Kayira D, Tegha G, Kamwendo D, Daza EJ, Fokar A, Kourtis AP, Jamieson DJ, van der Horst CM, Adair LS. Plasma and breast-milk selenium in HIV-infected Malawian mothers are positively associated with infant selenium status but are not associated with maternal supplementation: results of the Breastfeeding, Antiretrovirals, and Nutrition study. Am J Clin Nutr. 2014 Apr;99(4):950-6. doi: 10.3945/ajcn.113.073833. Epub 2014 Feb 5.

Results Reference

derived

PubMed Identifier

24381222

Citation

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. Changes in soluble transferrin receptor and hemoglobin concentrations in Malawian mothers are associated with those values in their exclusively breastfed, HIV-exposed infants. J Nutr. 2014 Mar;144(3):367-74. doi: 10.3945/jn.113.177915. Epub 2013 Dec 31.

Results Reference

derived

PubMed Identifier

23700341

Citation

Widen EM, Bentley ME, Kayira D, Chasela CS, Jamieson DJ, Tembo M, Soko A, Kourtis AP, Flax VL, Ellington SR, van der Horst CM, Adair LS; BAN Study team. Maternal weight loss during exclusive breastfeeding is associated with reduced weight and length gain in daughters of HIV-infected Malawian women. J Nutr. 2013 Jul;143(7):1168-75. doi: 10.3945/jn.112.171751. Epub 2013 May 22.

Results Reference

derived

PubMed Identifier

23468553

Citation

Flax VL, Bentley ME, Chasela CS, Kayira D, Hudgens MG, Kacheche KZ, Chavula C, Kourtis AP, Jamieson DJ, van der Horst CM, Adair LS. Lipid-based nutrient supplements are feasible as a breastmilk replacement for HIV-exposed infants from 24 to 48 weeks of age. J Nutr. 2013 May;143(5):701-7. doi: 10.3945/jn.112.168245. Epub 2013 Mar 6.

Results Reference

derived

PubMed Identifier

22649265

Citation

Flax VL, Bentley ME, Chasela CS, Kayira D, Hudgens MG, Knight RJ, Soko A, Jamieson DJ, van der Horst CM, Adair LS. Use of lipid-based nutrient supplements by HIV-infected Malawian women during lactation has no effect on infant growth from 0 to 24 weeks. J Nutr. 2012 Jul;142(7):1350-6. doi: 10.3945/jn.111.155598. Epub 2012 May 30.

Results Reference

derived

PubMed Identifier

22541418

Citation

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. Maternal and infant antiretroviral regimens to prevent postnatal HIV-1 transmission: 48-week follow-up of the BAN randomised controlled trial. Lancet. 2012 Jun 30;379(9835):2449-2458. doi: 10.1016/S0140-6736(12)60321-3. Epub 2012 Apr 26.

Results Reference

derived

PubMed Identifier

20554982

Citation

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. Maternal or infant antiretroviral drugs to reduce HIV-1 transmission. N Engl J Med. 2010 Jun 17;362(24):2271-81. doi: 10.1056/NEJMoa0911486.

Results Reference

derived

Learn more about this trial

Breastfeeding, Antiretroviral, and Nutrition Study

We'll reach out to this number within 24 hrs