Safety of Cotrimoxazole in HIV- and HAART-exposed Infants

HIV Infections Clinical Trial

Official title:

Safety of Cotrimoxazole in HIV- and HAART-exposed Infants in Botswana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086878
• Other study ID #: BHP031
• Secondary ID: 2P30AI060354-063
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2010
• Last updated: February 24, 2011
• Start date: February 2009
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review BoardBotswana: Health Research and Development CommitteeBotswana: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Anemia
• HIV Infections
• Immunologic Deficiency Syndromes
• Infant, Newborn
• Neutropenia

Intervention

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

Locations

Country	Name	City	State
Botswana	Princess Marina Hospital	Gaborone
Botswana	Scottish Livingstone Hospital	Molepolole	Kweneng

Sponsors (5)

Lead Sponsor	Collaborator
Harvard School of Public Health	Harvard Initiative for Global Health, John E. Fogarty International Center (FIC), National Institute of Allergy and Infectious Diseases (NIAID), The American Society of Tropical Medicine and Hygiene

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of severe or life-threatening anemia	incidence of severe or life-threatening anemia (as defined by DAIDS toxicity tables, 2004) between 1 and 6 month of life	between 1 to 6 months of life	Yes
Secondary	incidence of severe or life-threatening neutropenia	incidence of severe or life-threatening neutropenia (as defined by DAIDS toxicity tables, 2004) between 1 and 6 month of life	between 1 to 6 months of life	Yes
Secondary	composite severe morbidity and mortality	Composite of severe morbidity (grade 3 or 4 illnesses, DAIDS toxicity tables, 2004), hospitalization, and mortality.	between 1 and 6 months of life	Yes