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Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

This study has been completed.
Sponsor:
Collaborators:
Harvard Initiative for Global Health
The American Society of Tropical Medicine and Hygiene
Information provided by:
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01086878
First received: March 12, 2010
Last updated: February 24, 2011
Last verified: February 2011

March 12, 2010
February 24, 2011
February 2009
October 2010   (final data collection date for primary outcome measure)
incidence of severe or life-threatening anemia [ Time Frame: between 1 to 6 months of life ] [ Designated as safety issue: Yes ]
incidence of severe or life-threatening anemia (as defined by DAIDS toxicity tables, 2004) between 1 and 6 month of life
Same as current
Complete list of historical versions of study NCT01086878 on ClinicalTrials.gov Archive Site
  • incidence of severe or life-threatening neutropenia [ Time Frame: between 1 to 6 months of life ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Composite of severe morbidity (grade 3 or 4 illnesses, DAIDS toxicity tables, 2004), hospitalization, and mortality.
Same as current
Not Provided
Not Provided
 
Safety of Cotrimoxazole in HIV- and HAART-exposed Infants
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Acquired Immunodeficiency Syndrome
  • Infant, Newborn
  • Anemia
  • Neutropenia
  • HIV Infections
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
Experimental: Cotrimoxazole
Intervention: Drug: cotrimoxazole
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Botswana
 
NCT01086878
BHP031, 2P30AI060354-06, 3R24TW007988-01S1
No
Shahin Lockman, MD, Harvard School of Public Health
Harvard School of Public Health
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • John E. Fogarty International Center (FIC)
  • Harvard Initiative for Global Health
  • The American Society of Tropical Medicine and Hygiene
Principal Investigator: Shahin Lockman, MD Harvard School of Public Health
Harvard School of Public Health
February 2011

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