HIV InfectionsPhase 3NCT00164736

Breastfeeding, Antiretroviral, and Nutrition Study

A Phase 3 study testing Maternal zidovudine/lamivudine/lopinavir-ritonavir, Infant nevirapine and Maternal protein and calorie supplement in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Malawi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 14 years and olderHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: Maternal zidovudine/lamivudine/lopinavir-ritonavir, Infant nevirapine and Maternal protein and calorie supplement
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,369 participants
Where: 1 siteMalawi
Study dates: Mar 2004to Jan 2010
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Show all 20Show fewer

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Malawi1 site

Kamuzu Central Hospital, Bottom Hospital
Lilongwe

Other trials in Malawi

About this study

Official title: HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health

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

Read the 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.

Conditions: HIV Infections
Being tested: Maternal zidovudine/lamivudine/lopinavir-ritonavir, Infant nevirapine, Maternal protein and calorie supplement
Keywords: HIV, Clinical trial, breastfeeding, mother-to-child-transmission, nutrition, HIV Seronegativity
Medical subject headings: HIV Infections, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Maternal zidovudine/lamivudine/lopinavir-ritonavirDrug
Also called Combivir tabs (zidovudine 300mg and lamivudine 150mg), Aluvia tabs (lopinavir 200mg /ritonavir 50mg)
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 nevirapineDrug
Also called Viramune (Nevirapine) suspension 50mg/5ml
Nevirapine suspension once daily dose. 0-14days: 10mg; 3-18weeks: 20mg; 19-28weeks: 30mg.
To 28 weeks while breastfeeding.
Maternal protein and calorie supplementDietary supplement
Also called Produced by Nutriset. Daily dose: 2 sachets.
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 groups in NCT00164736
Study group	Role	What they receive
Maternal ARVs & Nutrition Supplement	Active comparator	Extended maternal ARVs for prophylaxis (for the infant) \& daily nutritional supplement given to the mother Receives: Drug: Maternal zidovudine/lamivudine/lopinavir-ritonavir; Dietary Supplement: Maternal protein and calorie supplement
Infant NVP & Nutrition Supplement	Active comparator	Extended infant nevirapine for prophylaxis \& daily nutritional supplment given to the mother Receives: Drug: Infant nevirapine; Dietary Supplement: Maternal protein and calorie supplement
Maternal ARVs & No Nutrition Supplement	Active comparator	Extended maternal ARVs for prophylaxis (for the infant) \& no nutritional supplement given to the mother Receives: Drug: Maternal zidovudine/lamivudine/lopinavir-ritonavir
Infant NVP & No Nutrition Supplement	Active comparator	Extended infant nevirapine for prophylaxis \& no nutritional supplment given to the mother Receives: Drug: Infant nevirapine
No Drugs & Nutrition Supplement	Active comparator	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. Receives: Dietary Supplement: Maternal protein and calorie supplement
No Drugs & No Nutrition Supplement	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Postpartum weight loss between delivery and 28 weeks
Measured: 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.)
Measured: birth to 28 weeks
Exclusive breastfeeding and breastfeeding cessation by 28 weeks
Measured: birth to 28 weeks

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2004Jan 2010

First posted14 Sep 2005 (estimated)
Study startMar 2004
Primary completionJan 2010
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 2,369 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00164736
Sponsor's protocol ID: CDC-NCCDPHP-3946
Other IDs: U48CCU409660, PA 04003 SIP 26-04
Status last verified: Apr 2010
First submitted: 13 Sep 2005
Last updated: 23 Apr 2010
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 26156797
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.
PubMed 25723140
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.
PubMed 24500152
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.
PubMed 24381222
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.
PubMed 23700341
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.
PubMed 23468553
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.
PubMed 22649265
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.
PubMed 22541418
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.
PubMed 20554982

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health
ClinicalTrials.gov ID: NCT00164736
Acronym / sponsor ID: CDC-NCCDPHP-3946
Conditions: HIV Infections
Keywords: HIV, Clinical trial, breastfeeding, mother-to-child-transmission, nutrition, HIV Seronegativity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,369 participants (actual)
Lead sponsor: Centers for Disease Control and PreventionUS federal agency
Collaborators: University of North Carolina, Chapel Hill, Kamuzu Central Hospital
Study start: Mar 2004
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 14 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Maternal ARVs & Nutrition Supplement	Active comparator	Drug: Maternal zidovudine/lamivudine/lopinavir-ritonavir, Dietary Supplement: Maternal protein and calorie supplementExtended maternal ARVs for prophylaxis (for the infant) \& daily nutritional supplement given to the mother
Infant NVP & Nutrition Supplement	Active comparator	Drug: Infant nevirapine, Dietary Supplement: Maternal protein and calorie supplementExtended infant nevirapine for prophylaxis \& daily nutritional supplment given to the mother
Maternal ARVs & No Nutrition Supplement	Active comparator	Drug: Maternal zidovudine/lamivudine/lopinavir-ritonavirExtended maternal ARVs for prophylaxis (for the infant) \& no nutritional supplement given to the mother
Infant NVP & No Nutrition Supplement	Active comparator	Drug: Infant nevirapineExtended infant nevirapine for prophylaxis \& no nutritional supplment given to the mother
No Drugs & Nutrition Supplement	Active comparator	Dietary Supplement: Maternal protein and calorie supplementNo 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 Drugs & No Nutrition Supplement	No intervention	–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.

Who may qualify

Ages: 14 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (20 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Maternal zidovudine/lamivudine/lopinavir-ritonavirAlso: Combivir tabs (zidovudine 300mg and lamivudine 150mg), Aluvia tabs (lopinavir 200mg /ritonavir 50mg)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.	Drug	Maternal ARVs & No Nutrition Supplement, Maternal ARVs & Nutrition Supplement
Infant nevirapineAlso: Viramune (Nevirapine) suspension 50mg/5mlNevirapine suspension once daily dose. 0-14days: 10mg; 3-18weeks: 20mg; 19-28weeks: 30mg. To 28 weeks while breastfeeding.	Drug	Infant NVP & No Nutrition Supplement, Infant NVP & Nutrition Supplement
Maternal protein and calorie supplementAlso: Produced by Nutriset. Daily dose: 2 sachets.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.	Dietary supplement	Infant NVP & Nutrition Supplement, Maternal ARVs & Nutrition Supplement, No Drugs & Nutrition Supplement

Primary outcome

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

3 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2010.
Derived from this study: PubMed 26156797Flax 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.
Derived from this study: PubMed 25723140Widen 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.
Derived from this study: PubMed 24500152Flax 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.
Derived from this study: PubMed 24381222Widen 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.
Derived from this study: PubMed 23700341Widen 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.
Derived from this study: PubMed 23468553Flax 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.
Derived from this study: PubMed 22649265Flax 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.
Derived from this study: PubMed 22541418Jamieson 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.
Derived from this study: PubMed 20554982Chasela 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.

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Charles van der Horst, MD study chair

University of North Carolina, Chapel Hill

Denise J Jamieson, MD, MPH principal investigator

CDC, Atlanta, GA

Peter Kazembe, MB ChB principal investigator

Kamuzu Central Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postpartum weight loss between delivery and 28 weeks (time frame: between delivery and 28 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00164736, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2010; AzTrials last refreshed its copy on 7 Nov 2026.