- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01613157
Predictors of Antiretroviral Pharmacokinetics in HIV-infected Women With Virologic Suppression
June 4, 2012 updated by: Canadian Immunodeficiency Research Collaborative
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
88
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5B 1L6
- Maple Leaf Medical Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
HIV positive patients
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mona Loutfy, MD, Sunnybrook and Women's College Health Science Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
November 5, 2009
First Submitted That Met QC Criteria
June 4, 2012
First Posted (Estimate)
June 7, 2012
Study Record Updates
Last Update Posted (Estimate)
June 7, 2012
Last Update Submitted That Met QC Criteria
June 4, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- CIHR-PK1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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