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

ClinicalTrials.gov processed this record on May 16, 2013