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Study of Pharmacokinetics in HIV-infected Women

NCT00433979 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2012-07-30

No results posted yet for this study

Summary

Women represent an increasing proportion of HIV cases globally and in Canada, yet are underrepresented in clinic trials. It is therefore critical to conduct this study on antiretroviral (ARV) pharmacokinetics (PK) in women to obtain additional information on ARV drug levels in women and their relation to adverse events (AEs).

The hypothesis for this study is three-fold:

1. that the mean drug levels (Cmin and Cmax) of ARVs will be significantly higher in our female population as compared to the mean drug levels in the historical HIV population (which is primarily men)
2. that ARV drug levels, particularly Cmin, are associated with body weight in women
3. that higher ARV drug levels, particularly Cmax, are associated with higher frequency and severity of AEs.

The objectives of this study are as follows:

Primary objectives:

1. To demonstrate that levels of Protease Inhibitors (PIs) and Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) are significantly higher in our female population as compared to the mean drug levels in the historical general population (which is primarily men).
2. To determine the association between PI and NNRTI minimum concentration (Cmin) and body weight in our female population.

Secondary objectives

1. To determine the association between maximum concentration (Cmax) and the frequency and severity of AEs as measured by the proportion of patients with grade 2 or higher laboratory or clinical AEs and the Symptom Index Score in women.
2. To determine the association between ARV drug levels and age, race, height, body mass index, adherence, hormonal levels and therapy, menstruation history, duration of HIV infection, duration on ARV therapy, baseline viral load, baseline CD4 count, present CD4 count, hepatitis B or C infection, class of ARVs, presence of ritonavir and other medications.

Conditions

  • HIV Infections

Interventions

DRUG

antiretroviral treatment

These antiretroviral drugs are a part of the participant's current drug regimen.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Women's College Hospital

    lead OTHER

Principal Investigators

  • Mona R Loutfy, MD FRCPC MPH · Women's College Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00433979 on ClinicalTrials.gov