Study of Adherence Effects and Clinical Outcomes of Kaletra Based HIV Antiviral Therapy

A Phase 4 study testing Lopinavir/Ritonavir in people with HIV Infection, run by Abbott at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to evaluate the effects of adherence on HIV antiviral response to treatment regimens containing Kaletra or other HIV protease inhibitors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infection
What is being tested?: Lopinavir/Ritonavir
How many people: 200 participants
Where: 1 siteUnited States
Study dates: Aug 2002to Feb 2007
Phase: Phase 4
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

Who may be able to join

Subject is documented HIV positive
Subject is greater than or equal to 18 years of age.
Subject currently on a regimen of either NNRTI + 2 Nucleoside Reverse Transcriptase Inhibitors NRTIs), two or three NRTIs who have failed regimen as evidenced by two consecutive viral loads with values over 1,000 copies/mL, the last one within the last three months, or
Naïve subjects to ARV regimen who are required to begin a PI containing HAART regimen, or
Subjects who have become intolerant to their current antiretroviral regimen and are required to be changed to a first time PI containing HAART regimen.
Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin >8.0 g/dL; Absolute neutrophil count >750 cells/mL; Platelet count >20,000/mL; ALT or AST <3 x Upper Limit of Normal (ULN); Creatinine <1.5 x ULN; Triglycerides <750 mg/dL.
Subjects have no have evidence of grade III or IV adverse event or laboratory abnormality.

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

Global Medical Information - Abbott
North Chicago, Illinois, 60064

Other trials in United States

About this study

Official title: Factors Associated With Adherence in a Cohort of HIV Positive Subjects on a First Time PI Containing HAART Regimen: Observational Study of the Impact of Adherence on Viral Load for a HAART Regimen Containing Kaletra vs Other Selected PI Containing HAART.

The purpose of this study is to evaluate the effects of adherence on HIV antiviral response to treatment regimens containing Kaletra or other HIV protease inhibitors.

Conditions: HIV Infection
Being tested: Lopinavir/Ritonavir
Keywords: HIV Infection, HAART, Lopinavir, Ritonavir, Treatment Experienced, Treatment Naive
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lopinavir/RitonavirDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Antiviral efficacy by HIV RNA

Secondary outcomes (1)

Treatment related discontinuations, predictors of adherence

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2002Feb 2007

First posted10 Oct 2005 (estimated)
Study startAug 2002
Study completionFeb 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionStudies 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00234962
Sponsor's protocol ID: PUER-01-001
Status last verified: Nov 2008
First submitted: 13 Sep 2005
Last updated: 21 Nov 2008
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Factors Associated With Adherence in a Cohort of HIV Positive Subjects on a First Time PI Containing HAART Regimen: Observational Study of the Impact of Adherence on Viral Load for a HAART Regimen Containing Kaletra vs Other Selected PI Containing HAART.
ClinicalTrials.gov ID: NCT00234962
Acronym / sponsor ID: PUER-01-001
Conditions: HIV Infection
Keywords: HIV Infection, HAART, Lopinavir, Ritonavir, Treatment Experienced, Treatment Naive
Phase: Phase 4
Study type: Interventional
Recruitment status: Terminated
Enrolment: 200 participants
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Aug 2002
Study completion: Feb 2007 (actual)
First posted: 10 Oct 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 evaluate the effects of adherence on HIV antiviral response to treatment regimens containing Kaletra or other HIV protease inhibitors.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subject is documented HIV positive
Subject is greater than or equal to 18 years of age.
Subject currently on a regimen of either NNRTI + 2 Nucleoside Reverse Transcriptase Inhibitors NRTIs), two or three NRTIs who have failed regimen as evidenced by two consecutive viral loads with values over 1,000 copies/mL, the last one within the last three months, or
Naïve subjects to ARV regimen who are required to begin a PI containing HAART regimen, or
Subjects who have become intolerant to their current antiretroviral regimen and are required to be changed to a first time PI containing HAART regimen.

Key exclusion criteria (1 listed)

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
Lopinavir/Ritonavir	Drug	–

Primary outcome

Antiviral efficacy by HIV RNA

1 secondary outcome

Treatment related discontinuations, predictors of adherence

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2008.

Related trials for HIV Infection

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.

Global Medical Information study director

Abbott

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lopinavir/Ritonavir in people with HIV Infection, run by Abbott 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 7 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: stopped early, as of the sponsor's last update on 21 Nov 2008. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

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?

Antiviral efficacy by HIV RNA. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00234962.

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 21 Nov 2008.