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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acquired Immunodeficiency Syndrome Infant, Newborn Anemia Neutropenia HIV Infections | Drug: cotrimoxazole | Phase 4 |
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 : | 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 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | October 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Cotrimoxazole |
Drug: cotrimoxazole
Daily oral cotrimoxazole suspension from 1 to 6 months of age at the following weight-based doses:
Other Names:
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- 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
- 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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
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

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
Botswana | |
Scottish Livingstone Hospital | |
Molepolole, Kweneng, Botswana | |
Princess Marina Hospital | |
Gaborone, Botswana |
Principal Investigator: | Shahin Lockman, MD | Harvard School of Public Health |
Responsible Party: | Shahin Lockman, MD, Harvard School of Public Health |
ClinicalTrials.gov Identifier: | NCT01086878 |
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 |
Antiretroviral Therapy, Highly Active Trimethoprim-Sulfamethoxazole Combination anemia |
neutropenia safety hematologic toxicity |
HIV Infections Acquired Immunodeficiency Syndrome Neutropenia Immunologic Deficiency Syndromes Hematologic Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Agranulocytosis Leukopenia Leukocyte Disorders |
Slow Virus Diseases Trimethoprim Trimethoprim, Sulfamethoxazole Drug Combination Sulfamethoxazole Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Cytochrome P-450 CYP2C8 Inhibitors |