Predictors of Antiretroviral Pharmacokinetics in HIV-infected Women With Virologic Suppression

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Canadian Immunodeficiency Research Collaborative

ClinicalTrials.gov Identifier:

NCT01613157

First received: November 5, 2009

Last updated: June 4, 2012

Last verified: June 2012

History of Changes

Purpose

The investigators would like to carry out this study to measure drug levels in HIV-infected women that are taking anti-HIV medications. This study will determine the predictors of high drug levels and will assess the association of drug levels and adverse events in women.

Condition
Human Immunodeficiency Virus


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Canadian Immunodeficiency Research Collaborative:


Enrollment:	88
Study Start Date:	January 2006
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

There have been tremendous advances in the treatment of HIV by combining 3 to 4 of the 20 anti-HIV medications available. Despite these advances, there remain several important complications related to the treatment, most importantly adverse events like nausea, diarrhea, liver toxicity and lipodystrophy (fat wasting or accumulation). Some studies have found that drug levels are higher in women and that these higher drug levels are associated with the increased toxicity in women. The reasons for the higher drug levels remain unclear. It is unknown whether these relate to hormonal influences, drug metabolism, adherence, fat distribution, body size or other factors. For this reason, we would like to carry out this study to measure drug levels in HIV-infected women that are taking anti-HIV medications. This study will determine the predictors of high drug levels and will assess the association of drug levels and adverse events in women.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

HIV positive patients

Criteria

Inclusion Criteria:

Are HIV infected
Are 18 years old or older
A biologic woman
Are taking their first combination Anti-retroviral regimen that includes a Protease Inhibitor or a Non-Nucleoside Reverse Transcriptase Inhibitor for the past three months with no changes in any part of the combination in that period
Are taking either a Protease Inhibitor or an Non-Nucleoside Reverse Transcriptase Inhibitor but not both
If taking a Protease Inhibitor, must be taking only one Protease Inhibitor excluding low dose ritonavir used as boosting
Have a viral load < 50 copies/mL on two occasions at least 1 month apart including a value at least three months before the baseline visit
Have signed and dated a full informed consent

Exclusion Criteria:

Have difficulty participating in a trial due to non-adherence or substance abuse
Pregnant or breast-feeding
Have malignancy receiving systemic chemotherapy
Have end-stage organ disease
Have another significant non-HIV underlying disease that might impinge upon disease progression or death

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613157

Locations


Canada, Ontario
Maple Leaf Medical Clinic
Toronto, Ontario, Canada, M5B 1L6

Sponsors and Collaborators

Canadian Immunodeficiency Research Collaborative

Investigators


Principal Investigator:	Mona Loutfy, MD	Sunnybrook and Women's College Health Science Centre

More Information

No publications provided


Responsible Party:	Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier:	NCT01613157 History of Changes
Other Study ID Numbers:	CIHR-PK1
Study First Received:	November 5, 2009
Last Updated:	June 4, 2012
Health Authority:	Canada: Health Canada

Keywords provided by Canadian Immunodeficiency Research Collaborative:


pharmacokinetics HIV infected women

Additional relevant MeSH terms:


Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections	Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases

ClinicalTrials.gov processed this record on February 27, 2015

To Top