Clinical trial NCT00164762: Nevirapine Resistance Study: Nevirapine Resistance Among HIV-Infected Mothers
Official title: Nevirapine Pharmacodynamics and Resistance Among HIV-Infected Mothers in Lilongwe, Malawi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
drug resistance
nevirapine
anti-retroviral drugs
mother-to-child transmission
Treatment Naive
pregnancy
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Kamuzu Central Hospital
name: University of North Carolina
First posted: 2005-09-14
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine whether the addition of zidovudine (ZDV) and lamivudine (3TC) at the onset of labor and for up to seven days postpartum to single-dose nevirapine (NVP) is associated with a lower prevalence of NVP-resistant HIV compared to single-dose NVP without ZDV+3TC.

Detailed description: The primary purpose of the Nevirapine Resistance Study is to compare nevirapine (NVP) resistance of HIV at two and six weeks postpartum in women who are participating in two different programs currently ongoing in Lilongwe, Malawi. The first program is through the HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health, also known as the Breastfeeding, Antiretrovirals and Nutrition (BAN) Study, a clinical trial where all enrolled women receive zidovudine (ZDV) and lamivudine (3TC) at the onset of labor and for up to seven days postpartum in addition to single-dose nevirapine (NVP). The second program is the Call to Action (CTA) program sponsored by the Malawi Ministry of Health and Population (MOHP) and UNC Project. The aim of the CTA program is to reduce mother to child transmission (MTCT) of HIV by providing women a single dose NVP to be taken at the onset of labor. Study participants are tested for NVP-resistant HIV at two and six weeks postpartum and the prevalence of NVP-resistant virus is compared among the two groups receiving different peripartum anti-retroviral regimens.

Eligibility criteria: Inclusion Criteria:

* HIV infected
* CD4 count \> 200 cells/μL
* ALT \< 2.5 x upper limit of normal (ULN)
* Hemoglobin (Hb) \> 7 g/dL
* Age \> 18 years, or \<18 years and married (considered emancipated minors in Malawi)
* Ability to give informed consent
* Evidence of HIV infection, as documented by 2 positive Enzyme-Linked Immunosorbent Assays (ELISA's); or 1 positive ELISA, and 1 Western blot (WB); or 2 separate concurrent rapid tests. These are the World Health Organization (WHO) acceptable criteria for diagnosing HIV-1 infection in adults.
* Currently pregnant (with a single or multiple fetuses)
* Gestation \< 34 weeks
* No serious current complications of pregnancy
* Intention to breastfeed
* Intention to deliver at the institution in which the study is based
* Other than HIV, no active serious infection, such as tuberculosis or other potentially serious illnesses
* No previous use of antiretrovirals including the HIVNET 012 regimen

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Area 25 Health Center
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Sherry L Farr, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Denise J Jamieson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Charles Van der Horst, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kamuzu Central Hospital
name: Peter Kazembe, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen LH, Hampel D, Shahab-Ferdows S, York ER, Adair LS, Flax VL, Tegha G, Chasela CS, Kamwendo D, Jamieson DJ, Bentley ME. Antiretroviral therapy provided to HIV-infected Malawian women in a randomized trial diminishes the positive effects of lipid-based nutrient supplements on breast-milk B vitamins. Am J Clin Nutr. 2015 Dec;102(6):1468-74. doi: 10.3945/ajcn.114.105106. Epub 2015 Nov 4.
citation: Kayira D, Bentley ME, Wiener J, Mkhomawanthu C, King CC, Chitsulo P, Chigwenembe M, Ellington S, Hosseinipour MC, Kourtis AP, Chasela C, Tembo M, Tohill B, Piwoz EG, Jamieson DJ, van der Horst C, Adair L; BAN Study Team. A lipid-based nutrient supplement mitigates weight loss among HIV-infected women in a factorial randomized trial to prevent mother-to-child transmission during exclusive breastfeeding. Am J Clin Nutr. 2012 Mar;95(3):759-65. doi: 10.3945/ajcn.111.018812. Epub 2012 Jan 18.
citation: Farr SL, Nelson JA, Ng'ombe TJ, Kourtis AP, Chasela C, Johnson JA, Kashuba AD, Tegha GL, Wiener J, Eron JJ, Banda HN, Mpaso M, Lipscomb J, Matiki C, Fiscus SA, Jamieson DJ, van der Horst C; BAN Study Team. Addition of 7 days of zidovudine plus lamivudine to peripartum single-dose nevirapine effectively reduces nevirapine resistance postpartum in HIV-infected mothers in Malawi. J Acquir Immune Defic Syndr. 2010 Aug;54(5):515-23. doi: 10.1097/qai.0b013e3181e3a70e.