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

NCT01613157 | Completed

• 1 other identifier: CIHR-PK1
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Immunodeficiency Virus

Keywords

pharmacokinetics; HIV infected women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV positive patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Immunodeficiency Research Collaborative: lead

Study Sites (1)

Maple Leaf Medical Clinic

Toronto, Ontario, M5B 1L6, Canada

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mona Loutfy, MD

  Sunnybrook and Women's College Health Science Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: June 7, 2012
• Study Start: January 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 7, 2012

Record last verified: 2012-06

Locations

CA (1)