Safety of Cotrimoxazole in HIV- and HAART-exposed Infants
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Acquired Immunodeficiency Syndrome Infant, Newborn Anemia Neutropenia HIV Infections |
Drug: cotrimoxazole |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Safety of Cotrimoxazole in HIV- and HAART-exposed Infants in Botswana |
- 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
- 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.
| Estimated Enrollment: | 222 |
| Study Start Date: | February 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cotrimoxazole |
Drug: cotrimoxazole
Daily oral cotrimoxazole suspension from 1 to 6 months of age at the following weight-based doses:
Other Names:
|
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.
Eligibility| Genders Eligible for Study: | Both |
| 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01086878
| Botswana | |
| Scottish Livingstone Hospital | |
| Molepolole, Kweneng, Botswana | |
| Princess Marina Hospital | |
| Gaborone, Botswana | |
| Principal Investigator: | Shahin Lockman, MD | Harvard School of Public Health |
More Information
No publications provided by Harvard School of Public Health
Additional 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, 3R24TW007988-01S1 |
| Study First Received: | March 12, 2010 |
| Last Updated: | February 24, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board Botswana: Health Research and Development Committee Botswana: Ministry of Health |
Keywords provided by Harvard School of Public Health:
|
Antiretroviral Therapy, Highly Active Trimethoprim-Sulfamethoxazole Combination anemia |
neutropenia safety hematologic toxicity |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases Sulfamethoxazole Trimethoprim |
Trimethoprim-Sulfamethoxazole Combination Anti-Infective Agents Anti-Infective Agents, Urinary Antimalarials Antiparasitic Agents Antiprotozoal Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Renal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015