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

November 5, 2009
June 4, 2012
January 2006
January 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01613157 on ClinicalTrials.gov Archive Site
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Predictors of Antiretroviral Pharmacokinetics in HIV-infected Women With Virologic Suppression
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

HIV positive patients

Human Immunodeficiency Virus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01613157
CIHR-PK1
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Canadian Immunodeficiency Research Collaborative
Canadian Immunodeficiency Research Collaborative
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Principal Investigator: Mona Loutfy, MD Sunnybrook and Women's College Health Science Centre
Canadian Immunodeficiency Research Collaborative
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP