Human Immunodeficiency VirusPhase 4NCT00648999
Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients
A Phase 4 study testing lopinavir/ritonavir in people with Human Immunodeficiency Virus, run by AbbVie (prior sponsor, Abbott) at 13 sites in Mexico.
Trial summary
To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- lopinavir/ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 13 sitesMexico
- Study dates
- Nov 2003to Dec 2006
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV Infected subjects
- Subjects failing in current HIV treatment, or
- Subjects with a viral load < 400 copies/mL and not tolerating their current HIV treatment.
Who cannot join
- Subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit
- Subject is pregnant
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Mexico13 sites
Site Ref # / Investigator 4073
Chihuahua City, 31310
Site Ref # / Investigator 4055
Culiacán, Sinaloa
Site Ref # / Investigator 4074
León, Guanajauto
Site Ref # / Investigator 4075
Mérida, Yucatán, 97219
Site Ref # / Investigator 4049
Mexico City, Mexico City, 01030
Site Ref # / Investigator 4050
Mexico City, Mexico City, 01120
Site Ref # / Investigator 4051
Mexico City, Mexico City, 09220
Site Ref # / Investigator 4077
Mexico City, Mexico City, 10300
Site Ref # / Investigator 4056
Mexico City, Mexico City
Site Ref # / Investigator 4054
Morelia, Michoacán
Site Ref # / Investigator 4052
Oaxaca City, Oaxaca
Site Ref # / Investigator 4053
Puebla City, Puebla, 72570
Site Ref # / Investigator 4072
Tepic, Nayarit
About this study
Official title: Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra
To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- lopinavir/ritonavir
- Keywords
- Kaletra
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lopinavir/ritonavirDrug
Also called ABT-378, Kaletra
lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: lopinavir/ritonavir |
| 2 | Active comparator | Not described Receives: Drug: lopinavir/ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Measured: Baseline, Week 4, Week 24 and Week 48
CD4
Measured: Baseline, Week 24 and Week 48
Secondary outcomes (1)
Adverse Event Monitoring
Measured: Baseline, Week 4, Week 24 and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startNov 2003
- Primary completionDec 2006
- Study completionDec 2006
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Canadas, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648999
- Sponsor's protocol ID
- MEXI-P01-02
- Status last verified
- Jan 2013
- First submitted
- 28 Mar 2008
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra
- ClinicalTrials.gov ID
- NCT00648999
- Acronym / sponsor ID
- MEXI-P01-02
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Kaletra
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 1 Apr 2008 (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.
To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: lopinavir/ritonavir |
| 2 | Active comparator | Drug: lopinavir/ritonavir |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- HIV Infected subjects
- Subjects failing in current HIV treatment, or
- Subjects with a viral load < 400 copies/mL and not tolerating their current HIV treatment.
Key exclusion criteria (2 listed)
- Subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit
- Subject is pregnant
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/ritonavirAlso: ABT-378, Kaletralopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment | Drug | 1, 2 |
Primary outcome
Quality of Life
Time frame: Baseline, Week 4, Week 24 and Week 48
CD4
Time frame: Baseline, Week 24 and Week 48
1 secondary outcome
Adverse Event Monitoring
Time frame: Baseline, Week 4, Week 24 and Week 48
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 15 Mar 2013.
- Related InfoLink provided by the sponsor.
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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.
Jose Canadas, MD study director
AbbVie
13 sites 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 Human Immunodeficiency Virus, run by AbbVie (prior sponsor, Abbott) at 13 sites in Mexico.
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 3 inclusion and 2 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 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Mexico. 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 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?
Quality of Life (time frame: Baseline, Week 4, Week 24 and Week 48). 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 15 Mar 2013.