HIV InfectionNCT00310726
Zambia Exclusive Breastfeeding Study
A study testing abrupt weaning at 4 months and Continued exclusive breastfeeding in people with HIV Infection, run by Boston Medical Center at 1 site in Zambia.
Trial summary
The study is designed as a randomized, controlled trial with specific observational objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be counselled to exclusively breastfeed through 4 months of age. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- HIV Infection
- What is being tested?
- abrupt weaning at 4 months and Continued exclusive breastfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,435 participants
- Where
- 1 siteZambia
- Study dates
- May 2001to Dec 2006
- Phase
- Interventional
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- HIV-positive pregnant women identified through VCT
- After counseling about the risks and benefits of feeding alternatives report that it is their intended decision to breastfeed
- Live within the catchment area of George or Chawama clinic
- Are between 30 - 34 wks gestation. (To insure that opportunity exists to receive a minimum of 2 lactation counseling sessions prior to delivery)
- Do not have any significant presenting illness that requires hospitalization
- Agree to adhere to the requirements of study participation (including exclusive breastfeeding and randomization into one of two infant feeding groups at four months).
- Willing to inform a household member (preferably husband/father) of HIV-status.
Who cannot join
- Lives outside of catchment area;
- Have known major illnesses likely to influence pregnancy outcome including diabetes, severe renal or heart disease, or active tuberculosis, prior to randomization;
- Does not intend to breastfeed;
- Prior enrollment in this study or concurrent enrollment in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Duration Exclusive Breastfeeding With Abrupt Weaning to Reduce the Risk of Mother-to-Child HIV Transmission
The study is designed as a randomized, controlled trial with specific observational objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be counselled to exclusively breastfeed through 4 months of age. All live-born children will be randomized (1:1) at birth to one of two counseling programs: A) to encourage abrupt weaning at 4 months of age, or B) to encourage exclusive breastfeeding through 6 months of age with the introduction of typical weaning foods ad lib.
Read the detailed description
It is well established that infants breast fed by their HIV-infected mothers are at risk of acquiring HIV infection through breast milk. However, in low resource settings, where the HIV epidemic now predominates, breast feeding cannot simply be replaced by breast milk substitutes since alternatives to breast milk are unavailable, unaffordable and unsafe. With this application we aim to test the safety and efficacy of short duration exclusive breast feeding to minimize risks of HIV transmission without increasing risks of non-HIV infant mortality. We propose a 5-year study of HIV-positive mothers and their children to be conducted in two urban primary health care clinics in Lusaka, Zambia. All HIV-positive women and their infants will be offered the two-dose nevirapine intervention and will be counseled about the risks and benefits of infant feeding options. Women who indicate their decision to breast feed will be eligible for enrollment into the study. A culturally appropriate, affordable and sustainable breast feeding education and support program to encourage exclusive breast feeding will be developed, and all women who elect to breast feed will be encouraged to exclusively breast feed to 4 months. Half of the women will be randomized to a counseling program which will encourage abrupt weaning to full replacement feeding at 4 months, and half will be randomized to a program to encourage continued breast feeding after 4 months with the usual introduction of weaning foods. Children will be followed for two years with regular medical histories, physical exams and clinical sampling. The primary objective of the study, based on the random assignment, is to compare HIV transmission rates and under-2 year mortality rates in children who abruptly wean at four months of age versus children who are weaned according to local practice. The second primary objective, based on observational comparisons, is to compare HIV transmission among infants whose mothers adhere to recommendations to exclusively breast feed with those who do not. Secondary objectives are to describe acute and chronic effects of abrupt weaning on child morbidity. The study proposes to test an inexpensive and potentially sustainable public health intervention to reduce HIV transmission through breast feeding while preserving benefits of breast feeding for other aspects of child health in a very low resource setting.
- Conditions
- HIV Infection
- Being tested
- abrupt weaning at 4 months, Continued exclusive breastfeeding
- Keywords
- Mother to Child Transmission of HIV, Postnatal HIV transmission, HIV, Breastfeeding, Perinatal HIV Transmission, 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.
abrupt weaning at 4 monthsOther
abrupt weaning at 4 months
Continued exclusive breastfeedingOther
Continued exclusive breastfeeding
| Study group | Role | What they receive |
|---|---|---|
| Abrupt Weaning | Experimental | Women were counseled to abruptly wean their child at 4 months of age. Receives: Other: abrupt weaning at 4 months |
| Exclusive breastfeeding per WHO guidelines | Active comparator | Women were counseled to adhere to the WHO recommendations for duration of exclusive breastfeeding. Receives: Other: Continued exclusive breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV infection detected by 4 months among children with no evidence of HIV infection at birth.
Measured: 24 months of age
Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2006 (estimated)
- Study startMay 2001
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), National Institutes of Health (NIH)
- Investigators
- Louise Kuhn, PhD, Principal investigator, Gertrude H. Sergievsky Center, and Department of Epidemiology, Mailman School of Public Health, Columbia UniversityDonald M Thea, MD, MSc, Principal investigator, Department of International Health, Boston University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310726
- Sponsor's protocol ID
- R01HD039611
- Other IDs
- R01HD039611
- Status last verified
- Jul 2011
- First submitted
- 3 Apr 2006
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thea DM, Vwalika C, Kasonde P, Kankasa C, Sinkala M, Semrau K, Shutes E, Ayash C, Tsai WY, Aldrovandi G, Kuhn L. Issues in the design of a clinical trial with a behavioral intervention--the Zambia exclusive breast-feeding study. Control Clin Trials. 2004 Aug;25(4):353-65. doi: 10.1016/j.cct.2004.06.005.
PubMed 15296810Kuhn L, Aldrovandi GM, Sinkala M, Kankasa C, Mwiya M, Thea DM. Potential impact of new WHO criteria for antiretroviral treatment for prevention of mother-to- child HIV transmission. AIDS. 2010 Jun 1;24(9):1374-7.
PubMed 20568677Albrecht S, Semrau K, Kasonde P, Sinkala M, Kankasa C, Vwalika C, Aldrovandi GM, Thea DM, Kuhn L. Predictors of nonadherence to single-dose nevirapine therapy for the prevention of mother-to-child HIV transmission. J Acquir Immune Defic Syndr. 2006 Jan 1;41(1):114-8. doi: 10.1097/01.qai.0000179425.27036.d7.
PubMed 16340483Kuhn L, Kasonde P, Sinkala M, Kankasa C, Semrau K, Scott N, Tsai WY, Vermund SH, Aldrovandi GM, Thea DM. Does severity of HIV disease in HIV-infected mothers affect mortality and morbidity among their uninfected infants? Clin Infect Dis. 2005 Dec 1;41(11):1654-61. doi: 10.1086/498029. Epub 2005 Oct 27.
PubMed 16267740Kuhn L, Kasonde P, Sinkala M, Kankasa C, Semrau K, Vwalika C, Tsai WY, Aldrovandi GM, Thea DM. Prolonged breast-feeding and mortality up to two years post-partum among HIV-positive women in Zambia. AIDS. 2005 Oct 14;19(15):1677-81. doi: 10.1097/01.aids.0000186817.38112.da.
PubMed 16184038Kuhn L, Trabattoni D, Kankasa C, Semrau K, Kasonde P, Lissoni F, Sinkala M, Ghosh M, Vwalika C, Aldrovandi GM, Thea DM, Clerici M. Alpha-defensins in the prevention of HIV transmission among breastfed infants. J Acquir Immune Defic Syndr. 2005 Jun 1;39(2):138-42.
PubMed 15905728Semrau K, Kuhn L, Vwalika C, Kasonde P, Sinkala M, Kankasa C, Shutes E, Aldrovandi G, Thea DM. Women in couples antenatal HIV counseling and testing are not more likely to report adverse social events. AIDS. 2005 Mar 24;19(6):603-9. doi: 10.1097/01.aids.0000163937.07026.a0.
PubMed 15802979Ghosh MK, Kuhn L, West J, Semrau K, Decker D, Thea DM, Aldrovandi GM. Quantitation of human immunodeficiency virus type 1 in breast milk. J Clin Microbiol. 2003 Jun;41(6):2465-70. doi: 10.1128/JCM.41.6.2465-2470.2003.
PubMed 12791866Sabbaj S, Edwards BH, Ghosh MK, Semrau K, Cheelo S, Thea DM, Kuhn L, Ritter GD, Mulligan MJ, Goepfert PA, Aldrovandi GM. Human immunodeficiency virus-specific CD8(+) T cells in human breast milk. J Virol. 2002 Aug;76(15):7365-73. doi: 10.1128/jvi.76.15.7365-7373.2002.
PubMed 12097549Fawzy A, Arpadi S, Kankasa C, Sinkala M, Mwiya M, Thea DM, Aldrovandi GM, Kuhn L. Early weaning increases diarrhea morbidity and mortality among uninfected children born to HIV-infected mothers in Zambia. J Infect Dis. 2011 May 1;203(9):1222-30. doi: 10.1093/infdis/jir019.
PubMed 21459815Gray RR, Salemi M, Lowe A, Nakamura KJ, Decker WD, Sinkala M, Kankasa C, Mulligan CJ, Thea DM, Kuhn L, Aldrovandi G, Goodenow MM. Multiple independent lineages of HIV-1 persist in breast milk and plasma. AIDS. 2011 Jan 14;25(2):143-52. doi: 10.1097/QAD.0b013e328340fdaf.
PubMed 21173592Murnane PM, Arpadi SM, Sinkala M, Kankasa C, Mwiya M, Kasonde P, Thea DM, Aldrovandi GM, Kuhn L. Lactation-associated postpartum weight changes among HIV-infected women in Zambia. Int J Epidemiol. 2010 Oct;39(5):1299-310. doi: 10.1093/ije/dyq065. Epub 2010 May 19.
PubMed 20484334Heath L, Conway S, Jones L, Semrau K, Nakamura K, Walter J, Decker WD, Hong J, Chen T, Heil M, Sinkala M, Kankasa C, Thea DM, Kuhn L, Mullins JI, Aldrovandi GM. Restriction of HIV-1 genotypes in breast milk does not account for the population transmission genetic bottleneck that occurs following transmission. PLoS One. 2010 Apr 20;5(4):e10213. doi: 10.1371/journal.pone.0010213.
PubMed 20422033Kuhn L, Sinkala M, Semrau K, Kankasa C, Kasonde P, Mwiya M, Hu CC, Tsai WY, Thea DM, Aldrovandi GM. Elevations in mortality associated with weaning persist into the second year of life among uninfected children born to HIV-infected mothers. Clin Infect Dis. 2010 Feb 1;50(3):437-44. doi: 10.1086/649886.
PubMed 20047479Walter J, Ghosh MK, Kuhn L, Semrau K, Sinkala M, Kankasa C, Thea DM, Aldrovandi GM. High concentrations of interleukin 15 in breast milk are associated with protection against postnatal HIV transmission. J Infect Dis. 2009 Nov 15;200(10):1498-502. doi: 10.1086/644603.
PubMed 19835475
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Duration Exclusive Breastfeeding With Abrupt Weaning to Reduce the Risk of Mother-to-Child HIV Transmission
- ClinicalTrials.gov ID
- NCT00310726
- Acronym / sponsor ID
- R01HD039611
- Conditions
- HIV Infection
- Keywords
- Mother to Child Transmission of HIV, Postnatal HIV transmission, HIV, Breastfeeding, Perinatal HIV Transmission, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,435 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), National Institutes of Health (NIH)
- Study start
- May 2001
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 4 Apr 2006 (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.
The study is designed as a randomized, controlled trial with specific observational objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be counselled to exclusively breastfeed through 4 months of age. All live-born children will be randomized (1:1) at birth to one of two counseling programs: A) to encourage abrupt weaning at 4 months of age, or B) to encourage exclusive breastfeeding through 6 months of age with the introduction of typical weaning foods ad lib.
Detailed description
It is well established that infants breast fed by their HIV-infected mothers are at risk of acquiring HIV infection through breast milk. However, in low resource settings, where the HIV epidemic now predominates, breast feeding cannot simply be replaced by breast milk substitutes since alternatives to breast milk are unavailable, unaffordable and unsafe. With this application we aim to test the safety and efficacy of short duration exclusive breast feeding to minimize risks of HIV transmission without increasing risks of non-HIV infant mortality. We propose a 5-year study of HIV-positive mothers and their children to be conducted in two urban primary health care clinics in Lusaka, Zambia. All HIV-positive women and their infants will be offered the two-dose nevirapine intervention and will be counseled about the risks and benefits of infant feeding options. Women who indicate their decision to breast feed will be eligible for enrollment into the study. A culturally appropriate, affordable and sustainable breast feeding education and support program to encourage exclusive breast feeding will be developed, and all women who elect to breast feed will be encouraged to exclusively breast feed to 4 months. Half of the women will be randomized to a counseling program which will encourage abrupt weaning to full replacement feeding at 4 months, and half will be randomized to a program to encourage continued breast feeding after 4 months with the usual introduction of weaning foods. Children will be followed for two years with regular medical histories, physical exams and clinical sampling. The primary objective of the study, based on the random assignment, is to compare HIV transmission rates and under-2 year mortality rates in children who abruptly wean at four months of age versus children who are weaned according to local practice. The second primary objective, based on observational comparisons, is to compare HIV transmission among infants whose mothers adhere to recommendations to exclusively breast feed with those who do not. Secondary objectives are to describe acute and chronic effects of abrupt weaning on child morbidity. The study proposes to test an inexpensive and potentially sustainable public health intervention to reduce HIV transmission through breast feeding while preserving benefits of breast feeding for other aspects of child health in a very low resource setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abrupt Weaning | Experimental | Other: abrupt weaning at 4 monthsWomen were counseled to abruptly wean their child at 4 months of age. |
| Exclusive breastfeeding per WHO guidelines | Active comparator | Other: Continued exclusive breastfeedingWomen were counseled to adhere to the WHO recommendations for duration of exclusive breastfeeding. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- HIV-positive pregnant women identified through VCT
- After counseling about the risks and benefits of feeding alternatives report that it is their intended decision to breastfeed
- Live within the catchment area of George or Chawama clinic
- Are between 30 - 34 wks gestation. (To insure that opportunity exists to receive a minimum of 2 lactation counseling sessions prior to delivery)
- Do not have any significant presenting illness that requires hospitalization
Key exclusion criteria (4 listed)
- Lives outside of catchment area;
- Have known major illnesses likely to influence pregnancy outcome including diabetes, severe renal or heart disease, or active tuberculosis, prior to randomization;
- Does not intend to breastfeed;
- Prior enrollment in this study or concurrent enrollment in another 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 |
|---|---|---|
| abrupt weaning at 4 monthsabrupt weaning at 4 months | Other | Abrupt Weaning |
| Continued exclusive breastfeedingContinued exclusive breastfeeding | Other | Exclusive breastfeeding per WHO guidelines |
Primary outcome
HIV infection detected by 4 months among children with no evidence of HIV infection at birth.
Time frame: 24 months of age
Magnitude of the reduction in mother-to-child HIV transmission and the magnitude of the increase in non-HIV-related under-2-year mortality, attributable to cessation of breastfeeding at 4 months.
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 27 Jul 2011.
- Background: PubMed 15296810Thea DM, Vwalika C, Kasonde P, Kankasa C, Sinkala M, Semrau K, Shutes E, Ayash C, Tsai WY, Aldrovandi G, Kuhn L. Issues in the design of a clinical trial with a behavioral intervention--the Zambia exclusive breast-feeding study. Control Clin Trials. 2004 Aug;25(4):353-65. doi: 10.1016/j.cct.2004.06.005.
- Background: PubMed 20568677Kuhn L, Aldrovandi GM, Sinkala M, Kankasa C, Mwiya M, Thea DM. Potential impact of new WHO criteria for antiretroviral treatment for prevention of mother-to- child HIV transmission. AIDS. 2010 Jun 1;24(9):1374-7.
- Results publication: PubMed 16340483Albrecht S, Semrau K, Kasonde P, Sinkala M, Kankasa C, Vwalika C, Aldrovandi GM, Thea DM, Kuhn L. Predictors of nonadherence to single-dose nevirapine therapy for the prevention of mother-to-child HIV transmission. J Acquir Immune Defic Syndr. 2006 Jan 1;41(1):114-8. doi: 10.1097/01.qai.0000179425.27036.d7.
- Results publication: PubMed 16267740Kuhn L, Kasonde P, Sinkala M, Kankasa C, Semrau K, Scott N, Tsai WY, Vermund SH, Aldrovandi GM, Thea DM. Does severity of HIV disease in HIV-infected mothers affect mortality and morbidity among their uninfected infants? Clin Infect Dis. 2005 Dec 1;41(11):1654-61. doi: 10.1086/498029. Epub 2005 Oct 27.
- Results publication: PubMed 16184038Kuhn L, Kasonde P, Sinkala M, Kankasa C, Semrau K, Vwalika C, Tsai WY, Aldrovandi GM, Thea DM. Prolonged breast-feeding and mortality up to two years post-partum among HIV-positive women in Zambia. AIDS. 2005 Oct 14;19(15):1677-81. doi: 10.1097/01.aids.0000186817.38112.da.
- Results publication: PubMed 15905728Kuhn L, Trabattoni D, Kankasa C, Semrau K, Kasonde P, Lissoni F, Sinkala M, Ghosh M, Vwalika C, Aldrovandi GM, Thea DM, Clerici M. Alpha-defensins in the prevention of HIV transmission among breastfed infants. J Acquir Immune Defic Syndr. 2005 Jun 1;39(2):138-42.
- Results publication: PubMed 15802979Semrau K, Kuhn L, Vwalika C, Kasonde P, Sinkala M, Kankasa C, Shutes E, Aldrovandi G, Thea DM. Women in couples antenatal HIV counseling and testing are not more likely to report adverse social events. AIDS. 2005 Mar 24;19(6):603-9. doi: 10.1097/01.aids.0000163937.07026.a0.
- Results publication: PubMed 12791866Ghosh MK, Kuhn L, West J, Semrau K, Decker D, Thea DM, Aldrovandi GM. Quantitation of human immunodeficiency virus type 1 in breast milk. J Clin Microbiol. 2003 Jun;41(6):2465-70. doi: 10.1128/JCM.41.6.2465-2470.2003.
- Results publication: PubMed 12097549Sabbaj S, Edwards BH, Ghosh MK, Semrau K, Cheelo S, Thea DM, Kuhn L, Ritter GD, Mulligan MJ, Goepfert PA, Aldrovandi GM. Human immunodeficiency virus-specific CD8(+) T cells in human breast milk. J Virol. 2002 Aug;76(15):7365-73. doi: 10.1128/jvi.76.15.7365-7373.2002.
- Results publication: PubMed 21459815Fawzy A, Arpadi S, Kankasa C, Sinkala M, Mwiya M, Thea DM, Aldrovandi GM, Kuhn L. Early weaning increases diarrhea morbidity and mortality among uninfected children born to HIV-infected mothers in Zambia. J Infect Dis. 2011 May 1;203(9):1222-30. doi: 10.1093/infdis/jir019.
- Results publication: PubMed 21173592Gray RR, Salemi M, Lowe A, Nakamura KJ, Decker WD, Sinkala M, Kankasa C, Mulligan CJ, Thea DM, Kuhn L, Aldrovandi G, Goodenow MM. Multiple independent lineages of HIV-1 persist in breast milk and plasma. AIDS. 2011 Jan 14;25(2):143-52. doi: 10.1097/QAD.0b013e328340fdaf.
- Results publication: PubMed 20484334Murnane PM, Arpadi SM, Sinkala M, Kankasa C, Mwiya M, Kasonde P, Thea DM, Aldrovandi GM, Kuhn L. Lactation-associated postpartum weight changes among HIV-infected women in Zambia. Int J Epidemiol. 2010 Oct;39(5):1299-310. doi: 10.1093/ije/dyq065. Epub 2010 May 19.
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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.
Louise Kuhn, PhD principal investigator
Gertrude H. Sergievsky Center, and Department of Epidemiology, Mailman School of Public Health, Columbia University
Donald M Thea, MD, MSc principal investigator
Department of International Health, Boston University School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abrupt weaning at 4 months and Continued exclusive breastfeeding in people with HIV Infection, run by Boston Medical Center at 1 site in Zambia.
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 4 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 27 Jul 2011. 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 Zambia. 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?
HIV infection detected by 4 months among children with no evidence of HIV infection at birth. (time frame: 24 months of age). The study lists 2 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 NCT00310726, which also lists 28 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 27 Jul 2011; AzTrials last refreshed its copy on 31 Oct 2026.