HIV InfectionsNCT00432783
A Comparison of Adherence Rates to Ritonavir and Its Accompanying Protease Inhibitor
An observational study of HIV Infections, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Pharmacologic boosting of protease inhibitors with ritonavir has become standard practice in antiretroviral therapy. Patients are instructed to take ritonavir at the same time as its accompanying protease inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Aug 2007
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from the Montefiore Medical Center Infectious Diseases Clinic who meet eligibility criteria described below.
Who may be able to join
- HIV infection, age>18 years, receiving therapy with ritonavir-boosted atazanavir or fosamprenavir, willingness to use MEMS caps, willingness to provide informed consent
Who cannot join
- Treatment with any medication that is contraindicated in combination with ritonavir or its accompanying protease inhibitor
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Comparison of Adherence Rates to Ritonavir (Soft-gel Capsules) and Its Accompanying Protease Inhibitor (PI) in Patients Receiving Ritonavir Boosted PI Regimens
Pharmacologic boosting of protease inhibitors with ritonavir has become standard practice in antiretroviral therapy. Patients are instructed to take ritonavir at the same time as its accompanying protease inhibitor. However, ritonavir is unpopular with many patients because of its large size and because of the recommended need for refrigeration. This study will test the hypothesis that adherence to ritonavir is inferior to adherence to its accompanying protease inhibitor in patients receiving such therapy.
Read the detailed description
The study staff will employ MEMS caps to prospectively measure adherence to ritonavir and its accompanying protease inhibitor over 24 weeks of follow-up. Paired sample t-tests will be employed to compare adherence to the two agents, and secondary analyses will be conducted to evaluate the chronologic concordance of ritonavir and accompanying protease inhibitor dosing.
- Conditions
- HIV Infections
- Keywords
- HIV, antiretroviral therapy, adherence, ritonavir
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startJun 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Jonathan Shuter, Montefiore Medical Center
- Investigators
- Jonathan Shuter, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432783
- Sponsor's protocol ID
- 06-01-023E
- Status last verified
- Apr 2018
- First submitted
- 6 Feb 2007
- Last updated
- 27 Apr 2018
- Results posted
- No
Publications
Shuter J, Sarlo JA, Rode RA, Zingman BS. Occurrence of selective ritonavir nonadherence and dose-staggering in recipients of boosted HIV-1 protease inhibitor therapy. HIV Clin Trials. 2009 May-Jun;10(3):135-42. doi: 10.1310/hct1003-135.
PubMed 19632952
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Adherence Rates to Ritonavir (Soft-gel Capsules) and Its Accompanying Protease Inhibitor (PI) in Patients Receiving Ritonavir Boosted PI Regimens
- ClinicalTrials.gov ID
- NCT00432783
- Acronym / sponsor ID
- 06-01-023E
- Conditions
- HIV Infections
- Keywords
- HIV, antiretroviral therapy, adherence, ritonavir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jun 2006 (actual)
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 8 Feb 2007 (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.
Pharmacologic boosting of protease inhibitors with ritonavir has become standard practice in antiretroviral therapy. Patients are instructed to take ritonavir at the same time as its accompanying protease inhibitor. However, ritonavir is unpopular with many patients because of its large size and because of the recommended need for refrigeration. This study will test the hypothesis that adherence to ritonavir is inferior to adherence to its accompanying protease inhibitor in patients receiving such therapy.
Detailed description
The study staff will employ MEMS caps to prospectively measure adherence to ritonavir and its accompanying protease inhibitor over 24 weeks of follow-up. Paired sample t-tests will be employed to compare adherence to the two agents, and secondary analyses will be conducted to evaluate the chronologic concordance of ritonavir and accompanying protease inhibitor dosing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the Montefiore Medical Center Infectious Diseases Clinic who meet eligibility criteria described below.
Key inclusion criteria (1 listed)
- HIV infection, age>18 years, receiving therapy with ritonavir-boosted atazanavir or fosamprenavir, willingness to use MEMS caps, willingness to provide informed consent
Key exclusion criteria (1 listed)
- Treatment with any medication that is contraindicated in combination with ritonavir or its accompanying protease inhibitor
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 27 Apr 2018.
- Derived from this study: PubMed 19632952Shuter J, Sarlo JA, Rode RA, Zingman BS. Occurrence of selective ritonavir nonadherence and dose-staggering in recipients of boosted HIV-1 protease inhibitor therapy. HIV Clin Trials. 2009 May-Jun;10(3):135-42. doi: 10.1310/hct1003-135.
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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.
Jonathan Shuter, MD principal investigator
Montefiore Medical Center
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 HIV Infections, run by Montefiore Medical Center at 1 site in United States.
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 1 inclusion and 1 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 27 Apr 2018. 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 United States. 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?
On the ClinicalTrials.gov record for NCT00432783, which also lists 1 linked publication.
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 27 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.