Nevirapine Resistance Study: Nevirapine Resistance Among HIV-Infected Mothers
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Purpose
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.
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | Nevirapine Pharmacodynamics and Resistance Among HIV-Infected Mothers in Lilongwe, Malawi |
| Enrollment: | 126 |
| Study Start Date: | June 2005 |
| Study Completion Date: | November 2006 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Malawi | |
| Area 25 Health Center | |
| Lilongwe, Malawi | |
| Principal Investigator: | Sherry L Farr, PhD | Centers for Disease Control and Prevention |
| Principal Investigator: | Denise J Jamieson, MD, MPH | Centers for Disease Control and Prevention |
| Principal Investigator: | Charles Van der Horst, MD | University of North Carolina, Chapel Hill |
| Principal Investigator: | Peter Kazembe, MB ChB | Kamuzu Central Hospital |
More Information
No publications provided by Centers for Disease Control and Prevention
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00164762 History of Changes |
| Other Study ID Numbers: | CDC-NCCDPHP-4535, SIP 26-04 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 27, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by Centers for Disease Control and Prevention:
|
HIV drug resistance nevirapine anti-retroviral drugs |
mother-to-child transmission Treatment Naive pregnancy |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Nevirapine Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013