Predictors of Antiretroviral Pharmacokinetics in HIV-infected Women With Virologic Suppression
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01613157 |
|
Recruitment Status :
Completed
First Posted : June 7, 2012
Last Update Posted : June 7, 2012
|
Sponsor:
Canadian Immunodeficiency Research Collaborative
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease |
|---|
| Human Immunodeficiency Virus |
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.
| Study Type : | Observational |
| Actual Enrollment : | 88 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Study Start Date : | January 2006 |
| Actual Primary Completion Date : | January 2009 |
| Actual Study Completion Date : | January 2009 |
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Canadian Immunodeficiency Research Collaborative |
| ClinicalTrials.gov Identifier: | NCT01613157 History of Changes |
| Other Study ID Numbers: |
CIHR-PK1 |
| First Posted: | June 7, 2012 Key Record Dates |
| Last Update Posted: | June 7, 2012 |
| Last Verified: | June 2012 |
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 |