Lactating Women on Select DOIBMS02NCT04862975
Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana
An observational study of Lactating Women on Select DOI and Breastmilk Fed Infants of Mothers on Select DOI, run by Duke University at 4 sites in South Africa.
Trial summary
The purpose of this study is to characterize the pharmacokinetics (PK) of understudied drugs administered to lactating women, receiving antiretroviral drugs per SOC as prescribed by their healthcare provider, and their co-enrolled infants ≤180 days of age who receive maternal breastmilk. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactating Women on Select DOI, Breastmilk Fed Infants of Mothers on Select DOI, HIV Infections
- What is being tested?
- Dolutegravir, Lamivudine and Emtricitabine
- How many people
- 164 participants
- Where
- 4 sitesSouth Africa
- Study dates
- 9 Jan 2024to 30 Jan 2025
- Phase
- Observational
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 50 eligible lactating women and their breastmilk fed infants per DOI will be co-enrolled. Participants may be enrolled for one or more DOIs with a single consent. The co-enrollment of mothers and more than 1 infant (multiple birth) is permitted.
Who may be able to join
- Lactating women ≥18 years of age who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.
- Informed consent, according to local IRB/REB/IEC guidelines, prior to any study-related procedures.
- If the mother is receiving more than one DOI, the mother must have taken all DOIs that she is receiving concomitantly for the 6 doses prior to sample collection.
- Mother participant is fluent in English or Setswana.
- Willing to provide at least 1 of the below required samples between the co-enrolled mother/infant pair:
- Maternal breastmilk
- Infant blood
Who cannot join
- Any concomitant condition which, in the opinion of the participant's healthcare provider, the site principal investigator (PI), a research nurse, or designee conducting the study, would preclude participation in the study.
- Known pregnancy of mother during sample collection.
- Mother has pumped any breastmilk at all in between the last 6 direct infant feedings prior to sample collection.
- Infant was fed breastmilk in any manner besides nursing at mother's breast for any of the last 6 feedings prior to sample collection.
- Previous enrollment on this study.
Trial locations and contacts
4 sites in 1 country.
South Africa4 sites
Botswana-UPenn Partnership
Botswana, Gaborone
Lesirane Clinic
Botswana, Gaborone
Mogoditshane Clinic KDC
Botswana, Gaborone
Old Naledi Clinic
Botswana, Gaborone
About this study
The purpose of this study is to characterize the pharmacokinetics (PK) of understudied drugs administered to lactating women, receiving antiretroviral drugs per SOC as prescribed by their healthcare provider, and their co-enrolled infants ≤180 days of age who receive maternal breastmilk.
Read the detailed description
Prospective, single-site, open label, PK and safety study. Co-enrollment of lactating women ≥18 years of age receiving drugs of interest (DOIs) per standard of care (SOC), as prescribed by their healthcare providers, and their infants who receive maternal breastmilk ≤180 days postpartum.
To understand drug transfer into breastmilk and determine subsequent infant exposure, biological samples will be collected from lactating women (blood and breastmilk) and infants (blood). The opportunistic design of this study will allow for a minimal risk study, an expanded enrollment net, evaluation of antiretroviral drugs, and capitalization of procedures performed per SOC to maximize study efficiency and data collection and minimize potential risk to participants. The data collected through this initiative will provide valuable PK, dosing, and safety information for drugs in this vulnerable population in order to inform public health.
- Conditions
- Lactating Women on Select DOI, Breastmilk Fed Infants of Mothers on Select DOI, HIV Infections
- Being tested
- Dolutegravir, Lamivudine, Emtricitabine, Tenofovir Disoproxil Fumarate
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolutegravirDrug
Also called Dolutegravir Sodium, DTG
Dolutegravir will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
LamivudineDrug
Also called 3TC
Lamivudine will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
EmtricitabineDrug
Also called FTC
Emtricitabine will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
Tenofovir Disoproxil FumarateDrug
Also called Tenofovir DF, TDF
Tenofovir Disoproxil Fumarate will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
| Study group | Role | What they receive |
|---|---|---|
| Drug of Interest | Lactating moms receiving one or more antiretroviral drugs and their breastmilk fed infants per standard of care. Receives: Drug: Dolutegravir; Drug: Lamivudine; Drug: Emtricitabine; Drug: Tenofovir Disoproxil Fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug concentration in maternal plasma
Drug concentration of a DOI in maternal plasma
Measured: Baseline
Drug concentration in maternal breastmilk
Drug concentration of a DOI in maternal breastmilk
Measured: Baseline
Drug concentration in infant plasma
Drug concentration of a DOI in infant plasma
Measured: Baseline
Milk/Plasma ratio
The drug exposure of selected DOIs will be evaluated using milk/plasma ratio
Measured: Baseline
Estimated daily infant dose
The drug exposure of selected DOIs will be evaluated using the estimated daily infant dose
Measured: Baseline
Relative infant dose
The drug exposure of selected DOIs will be evaluated using relative infant dose
Measured: Baseline
Infant/maternal exposure ratio
The drug exposure of selected DOIs will be evaluated using infant/maternal exposure ratio
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start9 Jan 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Lactating Women on Select DOIStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- Matt Kelly, MD, Principal investigator, Duke UniversityKevin Watt, MD, Principal investigator, University of UtahStephen Balevic, MD, Principal investigator, Duke UniversityAngelique Boutzoukas, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862975
- Sponsor's protocol ID
- Pro00107262
- Other IDs
- HHSN275201800003I
- Acronym
- BMS02
- Status last verified
- Feb 2025
- First submitted
- 23 Apr 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed, information about the study, including de-identified study data, will be submitted to the NIH data repository (https://dash.nichd.nih.gov and referred to below as "DASH"). With NIH approval, the data submitted to DASH may be used by other researchers for future research. The study data submitted to DASH will be de-identified, meaning it will not include any information that can identify the participant. The study team may also share the de-identified study data with other researchers. When the participant's de-identified study data are provided to other researchers for the purposes of future research, it will be done without obtaining additional permission from the participant.
Publications
Ip S, Chung M, Raman G, Trikalinos TA, Lau J. A summary of the Agency for Healthcare Research and Quality's evidence report on breastfeeding in developed countries. Breastfeed Med. 2009 Oct;4 Suppl 1:S17-30. doi: 10.1089/bfm.2009.0050.
PubMed 19827919Carpenter RG, Gardner A, Jepson M, Taylor EM, Salvin A, Sunderland R, Emery JL, Pursall E, Roe J. Prevention of unexpected infant death. Evaluation of the first seven years of the Sheffield Intervention Programme. Lancet. 1983 Apr 2;1(8327):723-7. doi: 10.1016/s0140-6736(83)92023-8.
PubMed 6132080Cunningham AS, Jelliffe DB, Jelliffe EF. Breast-feeding and health in the 1980s: a global epidemiologic review. J Pediatr. 1991 May;118(5):659-66. doi: 10.1016/s0022-3476(05)80023-x.
PubMed 2019919Ruiz-Palacios GM, Calva JJ, Pickering LK, Lopez-Vidal Y, Volkow P, Pezzarossi H, West MS. Protection of breast-fed infants against Campylobacter diarrhea by antibodies in human milk. J Pediatr. 1990 May;116(5):707-13. doi: 10.1016/s0022-3476(05)82652-6.
PubMed 2329419Koletzko S, Sherman P, Corey M, Griffiths A, Smith C. Role of infant feeding practices in development of Crohn's disease in childhood. BMJ. 1989 Jun 17;298(6688):1617-8. doi: 10.1136/bmj.298.6688.1617. No abstract available.
PubMed 2503151Mayer EJ, Hamman RF, Gay EC, Lezotte DC, Savitz DA, Klingensmith GJ. Reduced risk of IDDM among breast-fed children. The Colorado IDDM Registry. Diabetes. 1988 Dec;37(12):1625-32. doi: 10.2337/diab.37.12.1625.
PubMed 3192037Kramer MS, Aboud F, Mironova E, Vanilovich I, Platt RW, Matush L, Igumnov S, Fombonne E, Bogdanovich N, Ducruet T, Collet JP, Chalmers B, Hodnett E, Davidovsky S, Skugarevsky O, Trofimovich O, Kozlova L, Shapiro S; Promotion of Breastfeeding Intervention Trial (PROBIT) Study Group. Breastfeeding and child cognitive development: new evidence from a large randomized trial. Arch Gen Psychiatry. 2008 May;65(5):578-84. doi: 10.1001/archpsyc.65.5.578.
PubMed 18458209Huo D, Adebamowo CA, Ogundiran TO, Akang EE, Campbell O, Adenipekun A, Cummings S, Fackenthal J, Ademuyiwa F, Ahsan H, Olopade OI. Parity and breastfeeding are protective against breast cancer in Nigerian women. Br J Cancer. 2008 Mar 11;98(5):992-6. doi: 10.1038/sj.bjc.6604275. Epub 2008 Feb 26.
PubMed 18301401Lord SJ, Bernstein L, Johnson KA, Malone KE, McDonald JA, Marchbanks PA, Simon MS, Strom BL, Press MF, Folger SG, Burkman RT, Deapen D, Spirtas R, Ursin G. Breast cancer risk and hormone receptor status in older women by parity, age of first birth, and breastfeeding: a case-control study. Cancer Epidemiol Biomarkers Prev. 2008 Jul;17(7):1723-30. doi: 10.1158/1055-9965.EPI-07-2824.
PubMed 18628424Danforth KN, Tworoger SS, Hecht JL, Rosner BA, Colditz GA, Hankinson SE. Breastfeeding and risk of ovarian cancer in two prospective cohorts. Cancer Causes Control. 2007 Jun;18(5):517-23. doi: 10.1007/s10552-007-0130-2. Epub 2007 Apr 21.
PubMed 17450440Chasela 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 20554982Shapiro RL, Hughes MD, Ogwu A, Kitch D, Lockman S, Moffat C, Makhema J, Moyo S, Thior I, McIntosh K, van Widenfelt E, Leidner J, Powis K, Asmelash A, Tumbare E, Zwerski S, Sharma U, Handelsman E, Mburu K, Jayeoba O, Moko E, Souda S, Lubega E, Akhtar M, Wester C, Tuomola R, Snowden W, Martinez-Tristani M, Mazhani L, Essex M. Antiretroviral regimens in pregnancy and breast-feeding in Botswana. N Engl J Med. 2010 Jun 17;362(24):2282-94. doi: 10.1056/NEJMoa0907736.
PubMed 20554983Gardiner SJ, Kristensen JH, Begg EJ, Hackett LP, Wilson DA, Ilett KF, Kohan R, Rampono J. Transfer of olanzapine into breast milk, calculation of infant drug dose, and effect on breast-fed infants. Am J Psychiatry. 2003 Aug;160(8):1428-31. doi: 10.1176/appi.ajp.160.8.1428.
PubMed 12900304Atkinson HC, Begg EJ. Prediction of drug distribution into human milk from physicochemical characteristics. Clin Pharmacokinet. 1990 Feb;18(2):151-67. doi: 10.2165/00003088-199018020-00005.
PubMed 2318008Panchaud A, Garcia-Bournissen F, Csajka C, Kristensen JH, Taddio A, Ilett KF, Begg EJ, Ito S. Prediction of infant drug exposure through breastfeeding: population PK modeling and simulation of fluoxetine exposure. Clin Pharmacol Ther. 2011 Jun;89(6):830-6. doi: 10.1038/clpt.2011.23. Epub 2011 Apr 27.
PubMed 21525869
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana
- ClinicalTrials.gov ID
- NCT04862975
- Acronym / sponsor ID
- BMS02 / Pro00107262
- Conditions
- Lactating Women on Select DOI, Breastmilk Fed Infants of Mothers on Select DOI, HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Emmes Company, LLC
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 28 Apr 2021 (actual)
- 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.
The purpose of this study is to characterize the pharmacokinetics (PK) of understudied drugs administered to lactating women, receiving antiretroviral drugs per SOC as prescribed by their healthcare provider, and their co-enrolled infants ≤180 days of age who receive maternal breastmilk.
Detailed description
Prospective, single-site, open label, PK and safety study. Co-enrollment of lactating women ≥18 years of age receiving drugs of interest (DOIs) per standard of care (SOC), as prescribed by their healthcare providers, and their infants who receive maternal breastmilk ≤180 days postpartum.
To understand drug transfer into breastmilk and determine subsequent infant exposure, biological samples will be collected from lactating women (blood and breastmilk) and infants (blood). The opportunistic design of this study will allow for a minimal risk study, an expanded enrollment net, evaluation of antiretroviral drugs, and capitalization of procedures performed per SOC to maximize study efficiency and data collection and minimize potential risk to participants. The data collected through this initiative will provide valuable PK, dosing, and safety information for drugs in this vulnerable population in order to inform public health.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug of Interest | – | Drug: Dolutegravir, Drug: Lamivudine, Drug: Emtricitabine, Drug: Tenofovir Disoproxil FumarateLactating moms receiving one or more antiretroviral drugs and their breastmilk fed infants per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 50 eligible lactating women and their breastmilk fed infants per DOI will be co-enrolled. Participants may be enrolled for one or more DOIs with a single consent. The co-enrollment of mothers and more than 1 infant (multiple birth) is permitted.
Key inclusion criteria (7 listed)
- Lactating women ≥18 years of age who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.
- Informed consent, according to local IRB/REB/IEC guidelines, prior to any study-related procedures.
- If the mother is receiving more than one DOI, the mother must have taken all DOIs that she is receiving concomitantly for the 6 doses prior to sample collection.
- Mother participant is fluent in English or Setswana.
- Willing to provide at least 1 of the below required samples between the co-enrolled mother/infant pair:
Key exclusion criteria (5 listed)
- Any concomitant condition which, in the opinion of the participant's healthcare provider, the site principal investigator (PI), a research nurse, or designee conducting the study, would preclude participation in the study.
- Known pregnancy of mother during sample collection.
- Mother has pumped any breastmilk at all in between the last 6 direct infant feedings prior to sample collection.
- Infant was fed breastmilk in any manner besides nursing at mother's breast for any of the last 6 feedings prior to sample collection.
- Previous enrollment on this study.
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 |
|---|---|---|
| DolutegravirAlso: Dolutegravir Sodium, DTGDolutegravir will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study. | Drug | Drug of Interest |
| LamivudineAlso: 3TCLamivudine will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study. | Drug | Drug of Interest |
| EmtricitabineAlso: FTCEmtricitabine will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study. | Drug | Drug of Interest |
| Tenofovir Disoproxil FumarateAlso: Tenofovir DF, TDFTenofovir Disoproxil Fumarate will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study. | Drug | Drug of Interest |
Primary outcome
Drug concentration in maternal plasma
Time frame: Baseline
Drug concentration of a DOI in maternal plasma
Drug concentration in maternal breastmilk
Time frame: Baseline
Drug concentration of a DOI in maternal breastmilk
Drug concentration in infant plasma
Time frame: Baseline
Drug concentration of a DOI in infant plasma
Milk/Plasma ratio
Time frame: Baseline
The drug exposure of selected DOIs will be evaluated using milk/plasma ratio
Estimated daily infant dose
Time frame: Baseline
The drug exposure of selected DOIs will be evaluated using the estimated daily infant dose
Relative infant dose
Time frame: Baseline
The drug exposure of selected DOIs will be evaluated using relative infant dose
Infant/maternal exposure ratio
Time frame: Baseline
The drug exposure of selected DOIs will be evaluated using infant/maternal exposure ratio
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 6 Feb 2025.
- Background: PubMed 19827919Ip S, Chung M, Raman G, Trikalinos TA, Lau J. A summary of the Agency for Healthcare Research and Quality's evidence report on breastfeeding in developed countries. Breastfeed Med. 2009 Oct;4 Suppl 1:S17-30. doi: 10.1089/bfm.2009.0050.
- Background: PubMed 6132080Carpenter RG, Gardner A, Jepson M, Taylor EM, Salvin A, Sunderland R, Emery JL, Pursall E, Roe J. Prevention of unexpected infant death. Evaluation of the first seven years of the Sheffield Intervention Programme. Lancet. 1983 Apr 2;1(8327):723-7. doi: 10.1016/s0140-6736(83)92023-8.
- Background: PubMed 2019919Cunningham AS, Jelliffe DB, Jelliffe EF. Breast-feeding and health in the 1980s: a global epidemiologic review. J Pediatr. 1991 May;118(5):659-66. doi: 10.1016/s0022-3476(05)80023-x.
- Background: PubMed 2329419Ruiz-Palacios GM, Calva JJ, Pickering LK, Lopez-Vidal Y, Volkow P, Pezzarossi H, West MS. Protection of breast-fed infants against Campylobacter diarrhea by antibodies in human milk. J Pediatr. 1990 May;116(5):707-13. doi: 10.1016/s0022-3476(05)82652-6.
- Background: PubMed 2503151Koletzko S, Sherman P, Corey M, Griffiths A, Smith C. Role of infant feeding practices in development of Crohn's disease in childhood. BMJ. 1989 Jun 17;298(6688):1617-8. doi: 10.1136/bmj.298.6688.1617. No abstract available.
- Background: PubMed 3192037Mayer EJ, Hamman RF, Gay EC, Lezotte DC, Savitz DA, Klingensmith GJ. Reduced risk of IDDM among breast-fed children. The Colorado IDDM Registry. Diabetes. 1988 Dec;37(12):1625-32. doi: 10.2337/diab.37.12.1625.
- Background: PubMed 18458209Kramer MS, Aboud F, Mironova E, Vanilovich I, Platt RW, Matush L, Igumnov S, Fombonne E, Bogdanovich N, Ducruet T, Collet JP, Chalmers B, Hodnett E, Davidovsky S, Skugarevsky O, Trofimovich O, Kozlova L, Shapiro S; Promotion of Breastfeeding Intervention Trial (PROBIT) Study Group. Breastfeeding and child cognitive development: new evidence from a large randomized trial. Arch Gen Psychiatry. 2008 May;65(5):578-84. doi: 10.1001/archpsyc.65.5.578.
- Background: PubMed 18301401Huo D, Adebamowo CA, Ogundiran TO, Akang EE, Campbell O, Adenipekun A, Cummings S, Fackenthal J, Ademuyiwa F, Ahsan H, Olopade OI. Parity and breastfeeding are protective against breast cancer in Nigerian women. Br J Cancer. 2008 Mar 11;98(5):992-6. doi: 10.1038/sj.bjc.6604275. Epub 2008 Feb 26.
- Background: PubMed 18628424Lord SJ, Bernstein L, Johnson KA, Malone KE, McDonald JA, Marchbanks PA, Simon MS, Strom BL, Press MF, Folger SG, Burkman RT, Deapen D, Spirtas R, Ursin G. Breast cancer risk and hormone receptor status in older women by parity, age of first birth, and breastfeeding: a case-control study. Cancer Epidemiol Biomarkers Prev. 2008 Jul;17(7):1723-30. doi: 10.1158/1055-9965.EPI-07-2824.
- Background: PubMed 17450440Danforth KN, Tworoger SS, Hecht JL, Rosner BA, Colditz GA, Hankinson SE. Breastfeeding and risk of ovarian cancer in two prospective cohorts. Cancer Causes Control. 2007 Jun;18(5):517-23. doi: 10.1007/s10552-007-0130-2. Epub 2007 Apr 21.
- Background: 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.
- Background: PubMed 20554983Shapiro RL, Hughes MD, Ogwu A, Kitch D, Lockman S, Moffat C, Makhema J, Moyo S, Thior I, McIntosh K, van Widenfelt E, Leidner J, Powis K, Asmelash A, Tumbare E, Zwerski S, Sharma U, Handelsman E, Mburu K, Jayeoba O, Moko E, Souda S, Lubega E, Akhtar M, Wester C, Tuomola R, Snowden W, Martinez-Tristani M, Mazhani L, Essex M. Antiretroviral regimens in pregnancy and breast-feeding in Botswana. N Engl J Med. 2010 Jun 17;362(24):2282-94. doi: 10.1056/NEJMoa0907736.
- UNICEF Botswana Key Demographic IndicatorsLink provided by the sponsor.
- FDA: Clinical Lactation Studies: Considerations for Study Design Guidance for IndustryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the study is completed, information about the study, including de-identified study data, will be submitted to the NIH data repository (https://dash.nichd.nih.gov and referred to below as "DASH"). With NIH approval, the data submitted to DASH may be used by other researchers for future research. The study data submitted to DASH will be de-identified, meaning it will not include any information that can identify the participant. The study team may also share the de-identified study data with other researchers. When the participant's de-identified study data are provided to other researchers for the purposes of future research, it will be done without obtaining additional permission from the participant.
Related trials for Lactating Women on Select DOI
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Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI
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.
Matt Kelly, MD principal investigator
Duke University
Kevin Watt, MD principal investigator
University of Utah
Stephen Balevic, MD principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactating Women on Select DOI and Breastmilk Fed Infants of Mothers on Select DOI, run by Duke University at 4 sites in South Africa.
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 7 inclusion and 5 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa. 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.
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?
Drug concentration in maternal plasma (time frame: Baseline). The study lists 7 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 NCT04862975, which also lists 46 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 6 Feb 2025.