Predictors of Antiretroviral Pharmacokinetics in HIV-infected Women With Virologic Suppression
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ClinicalTrials.gov Identifier: NCT01613157 |
Recruitment Status
:
Completed
First Posted
: June 7, 2012
Last Update Posted
: June 7, 2012
|
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Condition or disease |
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Human Immunodeficiency Virus |
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 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
Canada, Ontario | |
Maple Leaf Medical Clinic | |
Toronto, Ontario, Canada, M5B 1L6 |
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 |