Predictors of Antiretroviral Pharmacokinetics in HIV-infected Women With Virologic Suppression
This study has been completed.
Sponsor:
Canadian Immunodeficiency Research Collaborative
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
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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:
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) |
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 (Adult, Senior) |
| 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
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: NCT01613157
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
| 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:
|
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on September 26, 2016