Study of Pharmacokinetics in HIV-infected Women

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Women's College Hospital
ClinicalTrials.gov Identifier:
NCT00433979
First received: February 9, 2007
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

Women represent an increasing proportion of HIV cases globally and in Canada, yet are underrepresented in clinic trials. It is therefore critical to conduct this study on antiretroviral (ARV) pharmacokinetics (PK) in women to obtain additional information on ARV drug levels in women and their relation to adverse events (AEs).

The hypothesis for this study is three-fold:

  1. that the mean drug levels (Cmin and Cmax) of ARVs will be significantly higher in our female population as compared to the mean drug levels in the historical HIV population (which is primarily men)
  2. that ARV drug levels, particularly Cmin, are associated with body weight in women
  3. that higher ARV drug levels, particularly Cmax, are associated with higher frequency and severity of AEs.

The objectives of this study are as follows:

Primary objectives:

  1. To demonstrate that levels of Protease Inhibitors (PIs) and Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) are significantly higher in our female population as compared to the mean drug levels in the historical general population (which is primarily men).
  2. To determine the association between PI and NNRTI minimum concentration (Cmin) and body weight in our female population.

Secondary objectives

  1. To determine the association between maximum concentration (Cmax) and the frequency and severity of AEs as measured by the proportion of patients with grade 2 or higher laboratory or clinical AEs and the Symptom Index Score in women.
  2. To determine the association between ARV drug levels and age, race, height, body mass index, adherence, hormonal levels and therapy, menstruation history, duration of HIV infection, duration on ARV therapy, baseline viral load, baseline CD4 count, present CD4 count, hepatitis B or C infection, class of ARVs, presence of ritonavir and other medications.

Condition Intervention
HIV Infections
Drug: antiretroviral treatment

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Predictors of Antiretroviral Pharmacokinetics in HIV-infected Women With Virologic Suppression on Combination Antiretroviral Therapy

Resource links provided by NLM:


Further study details as provided by Women's College Hospital:

Biospecimen Retention:   Samples Without DNA

Blood samples will be drawn before and after antiretroviral drugs are taken for visits 1-3.


Enrollment: 88
Study Start Date: February 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: antiretroviral treatment
    These antiretroviral drugs are a part of the participant's current drug regimen.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The patient population will consist of 80 HIV-infected women (who are on their first cART regimen containing either a PI or an NNRTI for at least three months and who have evidence of full virologic suppression (HIV RNA VL < 50 copies/mL) on at least two occasions at least one month apart. The first cART regimen can include ARV switches as long as these switches are not due to virologic failure. The patient population is being limited to women who have full virologic suppression to avoid inclusion of women with difficulty with drug adherence.

Criteria

Inclusion Criteria:

  • Patient must be HIV infected
  • Patient must be 18 years old or older
  • Patient must be a biologic woman
  • Patient must be taking her first combination ARV regimen that includes a PI or an NNRTI for the past three months with no changes in any agent of the combination in that period (first combination ARV regimen is defined as a regimen started when the patient was ARV-naïve; however switches are allowed as long as the switches are not for virologic failure)
  • Patient must be taking either a PI or an NNRTI but not both
  • If taking a PI, patient must be taking only one PI excluding low dose ritonavir used as boosting
  • Patient must have a viral load < 50 copies/mL on two occasions at least 1 month apart including a value within three months before the baseline visit
  • Patient has to have signed and dated a full informed consent

Exclusion Criteria:

  • Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
  • Patient who is pregnant or breast-feeding
  • Patient with a malignancy receiving systemic chemotherapy
  • Patient with end stage organ disease
  • Patient with other significant non-HIV underlying disease that might impinge upon disease progression or death
  • Patient who is not taking standard dosing of a PI or NNRTI as listed in Appendix G
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433979

Locations
Canada, British Columbia
Downtown Infectious Diseases Clinic
Vancouver, British Columbia, Canada, V6Z 2C7
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Children and Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Hamilton Health Sciences - McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Ottawa Health Research Institute
Ottawa, Ontario, Canada, K1Y 4E9
University of Ottawa Health Services
Ottawa, Ontario, Canada, K1N 6N5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canadian Immunodeficiency Research Collaborative
Toronto, Ontario, Canada, M5B 1L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Windsor Regional Hospital HIV Care Program
Windsor, Ontario, Canada, N8W 1E3
Canada, Quebec
Centre de recherche du Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2W 1T7
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
Canada
Chuq/Chul
Quebec, Canada, G1V 4G2
Sponsors and Collaborators
Women's College Hospital
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Mona R Loutfy, MD FRCPC MPH Women's College Hospital
  More Information

No publications provided by Women's College Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Mona Loutfy, Women's College Research Institute
ClinicalTrials.gov Identifier: NCT00433979     History of Changes
Other Study ID Numbers: HHP-79215
Study First Received: February 9, 2007
Last Updated: July 27, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Women's College Hospital:
Anti-HIV agents
Physiological Effects of Drugs
ARV-associated Adverse Events
HAART
Pharmacokinetics
Protease Inhibitors
Non-nucleoside Reverse Transcriptase Inhibitors
Women

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Reverse Transcriptase Inhibitors
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014