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Antiretroviral Drug Levels During and After Pregnancy

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ClinicalTrials.gov Identifier: NCT00616252
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : December 6, 2010
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Collaborator:
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Study Description
Brief Summary:

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 or disease
Pharmacokinetics

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of the Pharmacokinetics of Antiretroviral Agents in HIV Infected Ugandan Women During and After Pregnancy
Study Start Date : February 2008
Primary Completion Date : November 2008
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate potential changes in intracellular triphosphate concentration of NRTIs that may occur as a result of pregnancy [ Time Frame: 12 months ]
  3. To evaluate pharmacogenomic differences in this East African population. [ Time Frame: 12 months ]
  4. 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 ]

Biospecimen Retention:   Samples With DNA
Human plasma Red cell pellets

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV positive women attending ante-natal care clinic at Mulago Hospital, Kampala Uganda
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616252


Locations
Uganda
Infectious Diseases Institute, Faculty of Medicine, Makerere University
Kampala, Uganda, 22418
Sponsors and Collaborators
Makerere University
Northwestern University
Investigators
Principal Investigator: Concepta A Merry, PhD Trinity College Dublin
More Information

Responsible Party: Dr Concepta Merry, Infectious Diseases Institute
ClinicalTrials.gov Identifier: NCT00616252     History of Changes
Other Study ID Numbers: CPR 002
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: December 6, 2010
Last Verified: December 2010

Keywords provided by Makerere University:
Antiretroviral
Pharmacokinetics
Pregnancy

Additional relevant MeSH terms:
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents