Antiretroviral Drug Levels During and After Pregnancy
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In HIV-infected women, the use of combination therapy with antiretrovirals (ARV) in pregnancy prevents HIV related morbidity and mortality and prevents mother-to-child transmission of the HIV virus.
Specifically, suppression of the virus to an undetectable level is important during the delivery of the baby to minimize potential HIV exposure. In Sub-Saharan Africa, the use of ARV combinations containing nevirapine is the cornerstone of current HIV therapy, due to an affordable cost, availability in a fixed dose combination pill, and generic availability. Maintaining the efficacy and preventing development of resistance against this agent by the HIV virus is imperative, as second line therapies are often more difficult to obtain, are more expensive, and present more challenges in drug storage in clinics and in the community.
Pregnancy adds another dimension to the challenge of treating women with HIV, as the physiologic and metabolic changes can affect levels of antiretroviral agents in the body. Though these changes are known to exist, few trials have evaluated the effect of these factors on the pharmacokinetics of antiretroviral agents and their impact has yet to be demonstrated.
We wish to evaluate if the physiologic changes that occur during pregnancy impact the levels of stavudine, lamivudine, and nevirapine compared to those of a non-pregnant, HIV-infected Ugandan female. These data are imperative to ensure adequate suppression of the HIV virus throughout pregnancy.
Condition |
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Pharmacokinetics |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | Comparison of the Pharmacokinetics of Antiretroviral Agents in HIV Infected Ugandan Women During and After Pregnancy |
- To evaluate differences in the trough concentration (C12hr) of nevirapine during the second and third trimester of pregnancy and after delivery in the same patient [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To evaluate differences in the clearance (Cl/F), area under the curve (AUC), Volume of distribution (V/F), maximum concentration (Cmax), time to maximum concentration (Tmax), and half-life (T1/2) of nevirapine as a result of pregnancy. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To evaluate potential changes in intracellular triphosphate concentration of NRTIs that may occur as a result of pregnancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To evaluate pharmacogenomic differences in this East African population. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To establish pharmacokinetic levels seen in non-pregnant East African women as compared to the levels seen in the western population, based on the post-partum levels. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Human plasma Red cell pellets
Enrollment: | 16 |
Study Start Date: | February 2008 |
Study Completion Date: | September 2009 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
![](https://webarchive.library.unt.edu/web/20130317080332im_/http://clinicaltrials.gov/ct2/html/images/frame/plus.gif)
![](https://webarchive.library.unt.edu/web/20130317080332im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 39 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
HIV positive women attending ante-natal care clinic at Mulago Hospital, Kampala Uganda
Inclusion Criteria:
- HIV-infected pregnant female in her second or third trimester who requires ARV therapy during her pregnancy
- Antiretroviral therapy includes nevirapine in addition to two NRTI agents
- Informed consent obtained
Exclusion Criteria:
- If primary physician feels the required blood draws would be potentially dangerous to the patient or fetus
- Haemoglobin <8 g/dL
- Liver Function tests > 2x normal
- CD4 cell count >250 cells/mL if ART naive
- Calculated Creatinine Clearance < 30 ml/min at any visit during the study period
- Patients receiving any medications that may interact with the cytochrome p450 enzyme system metabolism of nevirapine
- Concurrent herbal medication use.
![](https://webarchive.library.unt.edu/web/20130317080332im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Uganda | |
Infectious Diseases Institute, Faculty of Medicine, Makerere University | |
Kampala, Uganda, 22418 |
Principal Investigator: | Concepta A Merry, PhD | Trinity College Dublin |
![](https://webarchive.library.unt.edu/web/20130317080332im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Dr Concepta Merry, Infectious Diseases Institute |
ClinicalTrials.gov Identifier: | NCT00616252 History of Changes |
Other Study ID Numbers: | CPR 002 |
Study First Received: | February 4, 2008 |
Last Updated: | December 3, 2010 |
Health Authority: | Uganda: National Council for Science and Technology Uganda: Research Ethics Committee |
Keywords provided by Makerere University:
Antiretroviral Pharmacokinetics Pregnancy |
Additional relevant MeSH terms:
Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 14, 2013