Acquired Immunodeficiency SyndromePhase 4NCT01086878
Safety of Cotrimoxazole in HIV- and HAART-exposed Infants
A Phase 4 study testing cotrimoxazole in people with Acquired Immunodeficiency Syndrome and Infant, Newborn, run by Harvard School of Public Health (HSPH) at 2 sites in Botswana.
Trial summary
The purpose of this study is to determine if prophylactic cotrimoxazole makes severe anemia or neutropenia more common in infants exposed to maternal HIV and combination antiretroviral therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, Infant, Newborn, Anemia
- What is being tested?
- cotrimoxazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 2 sitesBotswana
- Study dates
- Feb 2009to Oct 2010
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Both maternal and infant criteria need to be met:
Maternal Inclusion Criteria:
- documented HIV infection
- taking 3-drug highly active antiretroviral therapy at any point during pregnancy (note: can include 2 NRTI+NNRTI, 2NRTI+PI, or 3 NRTI)
- 21 years of age or older, and able and willing to sign informed consent
- Proof of Botswana Citizenship
Maternal Exclusion Criteria:
- involuntary incarceration
Infant Inclusion Criteria:
- younger than 42 days of age
- able to be brought to regular visits at study clinic until at least 6 months postpartum
Infant Exclusion Criteria:
- known pre-existing birth anomalies resulting in a high probability that the baby will not survive to 6 months
- known hypersensitivity to cotrimoxazole
Trial locations and contacts
2 sites in 1 country.
Botswana2 sites
Princess Marina Hospital
Gaborone, Gaborone
Scottish Livingstone Hospital
Molepolole, Kweneng District
About this study
Official title: Safety of Cotrimoxazole in HIV- and HAART-exposed Infants in Botswana
The purpose of this study is to determine if prophylactic cotrimoxazole makes severe anemia or neutropenia more common in infants exposed to maternal HIV and combination antiretroviral therapy.
Read the detailed description
Each year, more than 2 million children are born to HIV-infected women. The World Health Organization (WHO) recommends that these infants receive cotrimoxazole (CTX) prophylaxis starting at 4-6 weeks of age until the period of infant HIV transmission risk is over, and the infant is known to be HIV-uninfected. There is also increasing interest in studying CTX prophylaxis given to all infants of HIV-infected women at the time of initiation of replacement feeding, regardless of infant HIV infection status, to mitigate the high risk of infant morbidity and mortality associated with formula feeding in the developing world. However, infant in utero exposure to maternal antiretroviral drugs can lead to hematologic toxicities in infants. It is critical to know whether infant CTX prophylaxis exacerbates the hematologic toxicity associated with perinatal ARV exposure. This question, with broad public health implications, has never been studied.
We will study the hematologic toxicity associated with CTX prophylaxis given to infants exposed to maternal HAART in Botswana. We will use existing data from a large cohort that did not receive CTX, and enroll a smaller cohort that does receive CTX according to Botswana national guidelines.
- Being tested
- cotrimoxazole
- Keywords
- Antiretroviral Therapy, Highly Active, Trimethoprim-Sulfamethoxazole Combination, anemia, neutropenia, safety, hematologic toxicity
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Anemia, Neutropenia, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cotrimoxazoleDrug
Also called Bactrim, Septrim, Cotrim, Septra
Daily oral cotrimoxazole suspension from 1 to 6 months of age at the following weight-based doses:
- less than 5kg: 100mg sulfamethoxazole, 20mg trimethoprim
- greater than 5kg: 200mg sulfamethoxazole, 40mg trimethoprim
| Study group | Role | What they receive |
|---|---|---|
| Cotrimoxazole | Experimental | Not described Receives: Drug: cotrimoxazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of severe or life-threatening anemia
incidence of severe or life-threatening anemia (as defined by DAIDS toxicity tables, 2004) between 1 and 6 month of life
Measured: between 1 to 6 months of life
Secondary outcomes (2)
incidence of severe or life-threatening neutropenia
incidence of severe or life-threatening neutropenia (as defined by DAIDS toxicity tables, 2004) between 1 and 6 month of life
Measured: between 1 to 6 months of life
composite severe morbidity and mortality
Composite of severe morbidity (grade 3 or 4 illnesses, DAIDS toxicity tables, 2004), hospitalization, and mortality.
Measured: between 1 and 6 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startFeb 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Immunodeficiency SyndromeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Fogarty International Center of the National Institute of Health, Harvard Initiative for Global Health, The American Society of Tropical Medicine and Hygiene
- Investigators
- Shahin Lockman, MD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086878
- Sponsor's protocol ID
- BHP031
- Other IDs
- 2P30AI060354-06, 3R24TW007988-01S1
- Status last verified
- Feb 2011
- First submitted
- 12 Mar 2010
- Last updated
- 25 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Dryden-Peterson S, Jayeoba O, Hughes MD, Jibril H, McIntosh K, Modise TA, Asmelash A, Powis KM, Essex M, Shapiro RL, Lockman S. Cotrimoxazole prophylaxis and risk of severe anemia or severe neutropenia in HAART-exposed, HIV-uninfected infants. PLoS One. 2013 Sep 23;8(9):e74171. doi: 10.1371/journal.pone.0074171. eCollection 2013.
PubMed 24086319
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Cotrimoxazole in HIV- and HAART-exposed Infants in Botswana
- ClinicalTrials.gov ID
- NCT01086878
- Acronym / sponsor ID
- BHP031
- Keywords
- Antiretroviral Therapy, Highly Active, Trimethoprim-Sulfamethoxazole Combination, anemia, neutropenia, safety, hematologic toxicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Fogarty International Center of the National Institute of Health, Harvard Initiative for Global Health, The American Society of Tropical Medicine and Hygiene
- Study start
- Feb 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Mar 2010 (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 purpose of this study is to determine if prophylactic cotrimoxazole makes severe anemia or neutropenia more common in infants exposed to maternal HIV and combination antiretroviral therapy.
Detailed description
Each year, more than 2 million children are born to HIV-infected women. The World Health Organization (WHO) recommends that these infants receive cotrimoxazole (CTX) prophylaxis starting at 4-6 weeks of age until the period of infant HIV transmission risk is over, and the infant is known to be HIV-uninfected. There is also increasing interest in studying CTX prophylaxis given to all infants of HIV-infected women at the time of initiation of replacement feeding, regardless of infant HIV infection status, to mitigate the high risk of infant morbidity and mortality associated with formula feeding in the developing world. However, infant in utero exposure to maternal antiretroviral drugs can lead to hematologic toxicities in infants. It is critical to know whether infant CTX prophylaxis exacerbates the hematologic toxicity associated with perinatal ARV exposure. This question, with broad public health implications, has never been studied.
We will study the hematologic toxicity associated with CTX prophylaxis given to infants exposed to maternal HAART in Botswana. We will use existing data from a large cohort that did not receive CTX, and enroll a smaller cohort that does receive CTX according to Botswana national guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cotrimoxazole | Experimental | Drug: cotrimoxazole |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| cotrimoxazoleAlso: Bactrim, Septrim, Cotrim, SeptraDaily oral cotrimoxazole suspension from 1 to 6 months of age at the following weight-based doses: * less than 5kg: 100mg sulfamethoxazole, 20mg trimethoprim * greater than 5kg: 200mg sulfamethoxazole, 40mg trimethoprim | Drug | Cotrimoxazole |
Primary outcome
incidence of severe or life-threatening anemia
Time frame: between 1 to 6 months of life
incidence of severe or life-threatening anemia (as defined by DAIDS toxicity tables, 2004) between 1 and 6 month of life
2 secondary outcomes
incidence of severe or life-threatening neutropenia
Time frame: between 1 to 6 months of life
composite severe morbidity and mortality
Time frame: between 1 and 6 months of life
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 25 Feb 2011.
- Derived from this study: PubMed 24086319Dryden-Peterson S, Jayeoba O, Hughes MD, Jibril H, McIntosh K, Modise TA, Asmelash A, Powis KM, Essex M, Shapiro RL, Lockman S. Cotrimoxazole prophylaxis and risk of severe anemia or severe neutropenia in HAART-exposed, HIV-uninfected infants. PLoS One. 2013 Sep 23;8(9):e74171. doi: 10.1371/journal.pone.0074171. eCollection 2013.
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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.
Shahin Lockman, MD principal investigator
Harvard School of Public Health (HSPH)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cotrimoxazole in people with Acquired Immunodeficiency Syndrome and Infant, Newborn, run by Harvard School of Public Health (HSPH) at 2 sites in Botswana.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
incidence of severe or life-threatening anemia (time frame: between 1 to 6 months of life). 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 NCT01086878, which also lists 1 linked publication.
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 25 Feb 2011.