Clinical trial NCT01613157: Predictors of Antiretroviral Pharmacokinetics in HIV-infected Women With Virologic Suppression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: pharmacokinetics
HIV infected women
Lead sponsor: Canadian Immunodeficiency Research Collaborative
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV positive patients

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Maple Leaf Medical Clinic
state: Ontario
Study officials:
affiliation: Sunnybrook and Women's College Health Science Centre
name: Mona Loutfy, MD
role: PRINCIPAL_INVESTIGATOR
References: