HIV InfectionsNCT00205283
Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection
A study testing Nelfinavir in people with HIV Infections, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of prospective drug level monitoring and dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group of HIV-infected patients who have achieved virologic success while receiving a nelfinavir containing highly active antiretroviral therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nelfinavir
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to 1 Aug 2005
- Phase
- Interventional
- 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
- Adult, Older adult
Who may be able to join
- Antiretroviral naive or currently taking a nelfinavir containing HAART regimen where nelfinavir is the first protease inhibitor
- Patients willing to comply with the protocol
- Age greater than or equal to 18 years
- Virologically successful if already on an established regimen
Who cannot join
- Prior use of a protease inhibitor exclusive of nelfinavir
- Required use or concomitant use of drugs that may interact with or are contraindicated with nelfinavir
- Use of immunomodulators or vaccines for HIV disease
- Intercurrent illness at the time of enrollment that, in the clinician's judgement, could influence the HIV RNA concentration
- Baseline ALT levels greater than five times the upper limit of normal
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
The purpose of this study is to assess the impact of prospective drug level monitoring and dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group of HIV-infected patients who have achieved virologic success while receiving a nelfinavir containing highly active antiretroviral therapy (HAART) regimen.
- Conditions
- HIV Infections
- Being tested
- Nelfinavir
- Keywords
- HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NelfinavirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic response
Nelfinavir pharmacokinetics
Secondary outcomes (1)
Impact of nelfinavir and M8 pharmacokinetics on virologic response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2003
- Primary completion1 Aug 2005
- Study completion1 Aug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Agouron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Andrew Urban, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205283
- Sponsor's protocol ID
- 2002-212
- Status last verified
- Mar 2019
- First submitted
- 13 Sep 2005
- Last updated
- 22 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection
- ClinicalTrials.gov ID
- NCT00205283
- Acronym / sponsor ID
- 2002-212
- Conditions
- HIV Infections
- Keywords
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Agouron Pharmaceuticals
- Study start
- Aug 2003
- Primary completion
- 1 Aug 2005 (actual)
- Study completion
- 1 Aug 2005 (actual)
- First posted
- 20 Sep 2005 (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 purpose of this study is to assess the impact of prospective drug level monitoring and dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group of HIV-infected patients who have achieved virologic success while receiving a nelfinavir containing highly active antiretroviral therapy (HAART) regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Antiretroviral naive or currently taking a nelfinavir containing HAART regimen where nelfinavir is the first protease inhibitor
- Patients willing to comply with the protocol
- Age greater than or equal to 18 years
- Virologically successful if already on an established regimen
Key exclusion criteria (5 listed)
- Prior use of a protease inhibitor exclusive of nelfinavir
- Required use or concomitant use of drugs that may interact with or are contraindicated with nelfinavir
- Use of immunomodulators or vaccines for HIV disease
- Intercurrent illness at the time of enrollment that, in the clinician's judgement, could influence the HIV RNA concentration
- Baseline ALT levels greater than five times the upper limit of normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nelfinavir | Drug | – |
Primary outcome
Virologic response
Nelfinavir pharmacokinetics
1 secondary outcome
Impact of nelfinavir and M8 pharmacokinetics on virologic response
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 22 Mar 2019.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Andrew Urban, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nelfinavir in people with HIV Infections, run by University of Wisconsin, Madison 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 4 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 22 Mar 2019. 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.
What does the primary outcome measure?
Virologic response. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 22 Mar 2019.