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Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

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ClinicalTrials.gov Identifier: NCT01086878
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : February 25, 2011
Sponsor:
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
Information provided by:
Harvard School of Public Health

Tracking Information
First Submitted Date  ICMJE March 12, 2010
First Posted Date  ICMJE March 15, 2010
Last Update Posted Date February 25, 2011
Study Start Date  ICMJE February 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2010)
  • incidence of severe or life-threatening neutropenia [ Time Frame: between 1 to 6 months of life ]
    incidence of severe or life-threatening neutropenia (as defined by DAIDS toxicity tables, 2004) between 1 and 6 month of life
  • composite severe morbidity and mortality [ Time Frame: between 1 and 6 months of life ]
    Composite of severe morbidity (grade 3 or 4 illnesses, DAIDS toxicity tables, 2004), hospitalization, and mortality.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Cotrimoxazole in HIV- and HAART-exposed Infants
Official Title  ICMJE Safety of Cotrimoxazole in HIV- and HAART-exposed Infants in Botswana
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Acquired Immunodeficiency Syndrome
  • Infant, Newborn
  • Anemia
  • Neutropenia
  • HIV Infections
Intervention  ICMJE Drug: cotrimoxazole

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
Other Names:
  • Bactrim
  • Septrim
  • Cotrim
  • Septra
  • trimethoprim/sulfamethoxazole
  • trimethoprim-sulfamethoxazole
Study Arms  ICMJE Experimental: Cotrimoxazole
Intervention: Drug: cotrimoxazole
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 12, 2010)
222
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Botswana
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01086878
Other Study ID Numbers  ICMJE BHP031
2P30AI060354-06 ( U.S. NIH Grant/Contract )
3R24TW007988-01S1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shahin Lockman, MD, Harvard School of Public Health
Study Sponsor  ICMJE Harvard School of Public Health
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Shahin Lockman, MD Harvard School of Public Health
PRS Account Harvard School of Public Health
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP