Human Immunodeficiency VirusNCT01613157
Predictors of Antiretroviral Pharmacokinetics in HIV-infected Women With Virologic Suppression
An observational study of Human Immunodeficiency Virus, run by Canadian Immunodeficiency Research Collaborative at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Human Immunodeficiency Virus
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2006to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HIV positive patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus
- Keywords
- pharmacokinetics, HIV infected women
- Medical subject headings
- Acquired Immunodeficiency Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJan 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Immunodeficiency Research Collaborative
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mona Loutfy, MD, Principal investigator, Sunnybrook and Women's College Health Science Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613157
- Sponsor's protocol ID
- CIHR-PK1
- Status last verified
- Jun 2012
- First submitted
- 5 Nov 2009
- Last updated
- 7 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Antiretroviral Pharmacokinetics in HIV-infected Women With Virologic Suppression
- ClinicalTrials.gov ID
- NCT01613157
- Acronym / sponsor ID
- CIHR-PK1
- Conditions
- Human Immunodeficiency Virus
- Keywords
- pharmacokinetics, HIV infected women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Canadian Immunodeficiency Research CollaborativeUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV positive patients
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Loutfy, MD principal investigator
Sunnybrook and Women's College Health Science Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by Canadian Immunodeficiency Research Collaborative at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2012.