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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
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Acquired Immunodeficiency Syndrome Infant, Newborn Anemia Neutropenia HIV Infections Drug: cotrimoxazole Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety of Cotrimoxazole in HIV- and HAART-exposed Infants in Botswana
Study Start Date : February 2009
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cotrimoxazole 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

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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.

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086878

Scottish Livingstone Hospital
Molepolole, Kweneng, Botswana
Princess Marina Hospital
Gaborone, Botswana
Sponsors and Collaborators
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shahin Lockman, MD, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01086878     History of Changes
Other Study ID Numbers: BHP031
2P30AI060354-06 ( U.S. NIH Grant/Contract )
3R24TW007988-01S1 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: February 2011

Keywords provided by Harvard School of Public Health:
Antiretroviral Therapy, Highly Active
Trimethoprim-Sulfamethoxazole Combination
hematologic toxicity

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Leukocyte Disorders
Hematologic Diseases
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors