HIV InfectionsNCT00197652
Botswana Diarrheal Diseases Study
An observational study of HIV Infections, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
Trial summary
The goals of this study are to: 1. determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers. analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts of infected mothers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- HIV Infections
- How many people
- 1,350 participants
- Where
- 1 siteBotswana
- Study dates
- Mar 2001to Mar 2008
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Primary care clinic
Who may be able to join
- Subject is able to provide independent informed consent.
- Subject is able to complete a questionnaire as part of her enrollment visit and agrees to complete follow-up questionnaires monthly.
- Subject presents symptoms of acute diarrhea: at least 3 loose stools during 24 hours as reported by mother; persistent diarrhea: an episode of diarrhea lasting 14 days; recurrent diarrhea: a new episode of diarrhea after an interval of at least two diarrhea-free days.
- For HIV-infected subjects:
- Mother: HIV antibody is detected by dual HIV-1 ELISA and confirmed by western blot. Infant: HIV antigen is detected by PCR on 2 samples during the follow-up period, or on 1 sample followed by the death of the infant.
Who cannot join
- Subject cannot provide legal independent informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The goals of this study are to:
- determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers.
- analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts of infected mothers.
- comparison to rates among infants born to HIV uninfected mothers.
- link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.
- Conditions
- HIV Infections
- Keywords
- Prevention of Mother-Infant HIV Transmission
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diarrheal specimens from infants born to HIV infected mothers | 400 diarrheal specimens will suffice to determine the prevalence of specific pathogens in the region. Of these, 300 specimens will be collected from infants born to HIV infected mothers, and 100 specimens will be collected from infants born to HIV uninfected mothers. | |
| Breast milk from HIV infected and HIV uninfected women | Breast milk from HIV infected and HIV uninfected women who are breastfeeding is collected at 2 days, 2 weeks, 2 months, and 5 months post-partum. This breast milk will be compared for in vitro functional quality of immunoglobulins to selected diarrheal and respiratory pathogens. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2001
- Primary completionOct 2003
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Botswana Ministry of Health
- Responsible party
- Principal investigator, Roger Shapiro, Harvard School of Public Health (HSPH)
- Investigators
- Roger Shapiro, MD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197652
- Sponsor's protocol ID
- K23HD001330-05
- Status last verified
- Oct 2011
- First submitted
- 12 Sep 2005
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Shapiro RL, Smeaton L, Lockman S, Thior I, Rossenkhan R, Wester C, Stevens L, Moffat C, Arimi P, Ndase P, Asmelash A, Leidner J, Novitsky V, Makhema J, Essex M. Risk factors for early and late transmission of HIV via breast-feeding among infants born to HIV-infected women in a randomized clinical trial in Botswana. J Infect Dis. 2009 Feb 1;199(3):414-8. doi: 10.1086/596034.
PubMed 19090775Shapiro RL, Lockman S, Kim S, Smeaton L, Rahkola JT, Thior I, Wester C, Moffat C, Arimi P, Ndase P, Asmelash A, Stevens L, Montano M, Makhema J, Essex M, Janoff EN. Infant morbidity, mortality, and breast milk immunologic profiles among breast-feeding HIV-infected and HIV-uninfected women in Botswana. J Infect Dis. 2007 Aug 15;196(4):562-9. doi: 10.1086/519847. Epub 2007 Jul 9.
PubMed 17624842
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botswana Diarrheal Diseases Study
- ClinicalTrials.gov ID
- NCT00197652
- Acronym / sponsor ID
- K23HD001330-05
- Conditions
- HIV Infections
- Keywords
- Prevention of Mother-Infant HIV Transmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,350 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Botswana Ministry of Health
- Study start
- Mar 2001
- Primary completion
- Oct 2003 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 20 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.
The goals of this study are to:
- determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers.
- analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts of infected mothers.
- comparison to rates among infants born to HIV uninfected mothers.
- link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diarrheal specimens from infants born to HIV infected mothers | – | –400 diarrheal specimens will suffice to determine the prevalence of specific pathogens in the region. Of these, 300 specimens will be collected from infants born to HIV infected mothers, and 100 specimens will be collected from infants born to HIV uninfected mothers. |
| Breast milk from HIV infected and HIV uninfected women | – | –Breast milk from HIV infected and HIV uninfected women who are breastfeeding is collected at 2 days, 2 weeks, 2 months, and 5 months post-partum. This breast milk will be compared for in vitro functional quality of immunoglobulins to selected diarrheal and respiratory pathogens. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primary care clinic
Key inclusion criteria (5 listed)
- Subject is able to provide independent informed consent.
- Subject is able to complete a questionnaire as part of her enrollment visit and agrees to complete follow-up questionnaires monthly.
- Subject presents symptoms of acute diarrhea: at least 3 loose stools during 24 hours as reported by mother; persistent diarrhea: an episode of diarrhea lasting 14 days; recurrent diarrhea: a new episode of diarrhea after an interval of at least two diarrhea-free days.
- Mother: HIV antibody is detected by dual HIV-1 ELISA and confirmed by western blot. Infant: HIV antigen is detected by PCR on 2 samples during the follow-up period, or on 1 sample followed by the death of the infant.
Key exclusion criteria (1 listed)
- Subject cannot provide legal independent informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE
Time frame: 24 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 7 Oct 2011.
- Derived from this study: PubMed 19090775Shapiro RL, Smeaton L, Lockman S, Thior I, Rossenkhan R, Wester C, Stevens L, Moffat C, Arimi P, Ndase P, Asmelash A, Leidner J, Novitsky V, Makhema J, Essex M. Risk factors for early and late transmission of HIV via breast-feeding among infants born to HIV-infected women in a randomized clinical trial in Botswana. J Infect Dis. 2009 Feb 1;199(3):414-8. doi: 10.1086/596034.
- Derived from this study: PubMed 17624842Shapiro RL, Lockman S, Kim S, Smeaton L, Rahkola JT, Thior I, Wester C, Moffat C, Arimi P, Ndase P, Asmelash A, Stevens L, Montano M, Makhema J, Essex M, Janoff EN. Infant morbidity, mortality, and breast milk immunologic profiles among breast-feeding HIV-infected and HIV-uninfected women in Botswana. J Infect Dis. 2007 Aug 15;196(4):562-9. doi: 10.1086/519847. Epub 2007 Jul 9.
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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.
Roger Shapiro, MD principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
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 5 inclusion and 1 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 7 Oct 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 Botswana. 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?
OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE (time frame: 24 months). 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 NCT00197652, which also lists 2 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 7 Oct 2011; AzTrials last refreshed its copy on 28 Oct 2026.