NCT00164762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

October 1, 2007

Status Verified

September 1, 2007

First QC Date

September 12, 2005

Last Update Submit

September 27, 2007

Conditions

HIV Infections

Keywords

HIVdrug resistancenevirapineanti-retroviral drugsmother-to-child transmissionTreatment Naivepregnancy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Area 25 Health Center

Lilongwe, Malawi

Location

Related Publications (3)

  • 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.

    PMID: 26537941DERIVED

  • 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.

    PMID: 22258269DERIVED

  • 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.

    PMID: 20672451DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

June 1, 2005

Study Completion

November 1, 2006

Last Updated

October 1, 2007

Record last verified: 2007-09

Locations

MA(1)