The Effect of Pregnancy on the PK of Isentress®: A Longitudinal Investigation in the Second and Third Trimesters
Withdrawn
- Conditions
- HIVPregnancy
- Registration Number
- NCT01251601
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
The purpose of this study is to determine whether pregnancy affects the blood concentrations of raltegravir by comparing the second trimester and third trimester drug concentrations with post partum.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- HIV Infected
- Pregnant
- At least 18 years of age
- Planning to initiate or currently received raltegravir as part of an antiretroviral regimen with plans to continue at least 8-10 weeks post partum
Exclusion Criteria
- Less than 18 years of age
- Hemoglobin <9 g/dL or Hematocrit <27.3 at screening
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does pregnancy alter raltegravir pharmacokinetics in HIV-infected women during second/third trimesters?
What molecular mechanisms link integrase strand transfer inhibitor metabolism to gestational changes in HIV treatment?
Are there biomarkers predicting raltegravir efficacy or safety in pregnant HIV patients compared to non-pregnant cohorts?
How do adverse events of raltegravir in pregnancy compare to INSTIs like dolutegravir or elvitegravir in observational studies?
What role do integrase inhibitors play in combination antiretroviral therapy for HIV-1 during gestation?