HIV InfectionsNCT00164762
Nevirapine Resistance Study: Nevirapine Resistance Among HIV-Infected Mothers
An observational study of HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections
- How many people
- 126 participants
- Where
- 1 siteMalawi
- Study dates
- Jun 2005to Nov 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nevirapine Pharmacodynamics and Resistance Among HIV-Infected Mothers in Lilongwe, Malawi
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.
Read the 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.
- Conditions
- HIV Infections
- Keywords
- HIV, drug resistance, nevirapine, anti-retroviral drugs, mother-to-child transmission, Treatment Naive, pregnancy
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJun 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Kamuzu Central Hospital, University of North Carolina
- Investigators
- Sherry L Farr, PhD, Principal investigator, Centers for Disease Control and PreventionDenise J Jamieson, MD, MPH, Principal investigator, Centers for Disease Control and PreventionCharles Van der Horst, MD, Principal investigator, University of North Carolina, Chapel HillPeter Kazembe, MB ChB, Principal investigator, Kamuzu Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164762
- Sponsor's protocol ID
- CDC-NCCDPHP-4535
- Other IDs
- SIP 26-04
- Status last verified
- Sep 2007
- First submitted
- 12 Sep 2005
- Last updated
- 1 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26537941Kayira 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.
PubMed 22258269Farr 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.
PubMed 20672451
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nevirapine Pharmacodynamics and Resistance Among HIV-Infected Mothers in Lilongwe, Malawi
- ClinicalTrials.gov ID
- NCT00164762
- Acronym / sponsor ID
- CDC-NCCDPHP-4535
- Conditions
- HIV Infections
- Keywords
- HIV, drug resistance, nevirapine, anti-retroviral drugs, mother-to-child transmission, Treatment Naive, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Kamuzu Central Hospital, University of North Carolina
- Study start
- Jun 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2007.
- Derived from this study: PubMed 26537941Allen 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.
- Derived from this study: PubMed 22258269Kayira 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.
- Derived from this study: PubMed 20672451Farr 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherry L Farr, PhD principal investigator
Centers for Disease Control and Prevention
Denise J Jamieson, MD, MPH principal investigator
Centers for Disease Control and Prevention
Charles Van der Horst, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Centers for Disease Control and Prevention at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00164762, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2007.