NCT01251601

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Status
withdrawn

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

November 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

February 28, 2024

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

November 30, 2010

Last Update Submit

February 26, 2024

Conditions

HIVPregnancy

Study Arms (1)

Raltegravir in Pregnancy

HIV positive pregnant women currently on raltegravir as part of combination antiretroviral therapy

Other: Pharmacokinetics

Interventions

PharmacokineticsOTHER

Up to three 12 hour PK sampling sessions, one in the second trimester, one in the third trimester and one post partum

Raltegravir in Pregnancy

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited by their HIV clinic providers

You may qualify if:

  • 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

You may not qualify if:

  • Less than 18 years of age
  • Hemoglobin \<9 g/dL or Hematocrit \<27.3 at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Pharmacokinetics

Intervention Hierarchy (Ancestors)

MetabolismPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Officials

  • Angela DM Kashuba, PharmD

    UNC Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Kristine B Patterson, MD

    UNC Chapel Hill

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 2, 2010

Study Start

November 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

February 28, 2024

Record last verified: 2012-01