HIV InfectionPhase 3KALEADNCT00234910
Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients
A Phase 3 study testing Tenofovir DF and lopinavir/ritonavir with 2 Nucleoside RTIs in people with HIV Infection, run by Abbott at 1 site in United States.
Trial summary
The purpose of this study is to obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm. 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?
- Tenofovir DF and lopinavir/ritonavir with 2 Nucleoside RTIs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jun 2008
- Phase
- Phase 3
- 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
- HIV positive
- >18 years of age
- HIV RNA> 400 copies/mL
- Any CD 4 cell count
- Antiretroviral naïve
- No acute illness
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Global Medical Information-Abbott
Abbott Park, Illinois, 60064
About this study
Official title: A Phase III, Open Label, Randomized, Comparative Study of the Antiviral Efficacy of ARV Therapy With Lopinavir/Ritonavir (LPV/r-Kaletra) in Combination With Tenofovir (TDF) Versus Standard of Care (Kaletra in Combination With 2 Nucleoside RTIs) in naïve-HIV-1 Positive Patients
The purpose of this study is to obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm.
- Conditions
- HIV Infection
- Being tested
- Tenofovir DF, lopinavir/ritonavir with 2 Nucleoside RTIs
- Keywords
- Lopinavir, Ritonavir, Kaletra, Tenofovir, HIV infection, 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.
Tenofovir DFDrug
TDF 300mg QD for 72 wks
lopinavir/ritonavir with 2 Nucleoside RTIsDrug
Also called ABT-378, Kaletra, lopinavir/ritonavir
LPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 2 drug arm Receives: Drug: Tenofovir DF; Drug: lopinavir/ritonavir with 2 Nucleoside RTIs |
| B | Active comparator | 3 drug arm, SOC Receives: Drug: lopinavir/ritonavir with 2 Nucleoside RTIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiviral efficacy by HIV RNA
Measured: 72 wks
Incidence of adverse events
Measured: 72 wks
Secondary outcomes (1)
Adherence and quality of life
Measured: 72 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startJan 2005
- Primary completionJun 2007
- Study completionJun 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Umberto di Luzio Paparatti, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234910
- Sponsor's protocol ID
- ITAL-04-002
- Other IDs
- EUDRACT 2004-000786-35, KALEAD
- Acronym
- KALEAD
- Status last verified
- Jul 2008
- First submitted
- 13 Sep 2005
- Last updated
- 10 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open Label, Randomized, Comparative Study of the Antiviral Efficacy of ARV Therapy With Lopinavir/Ritonavir (LPV/r-Kaletra) in Combination With Tenofovir (TDF) Versus Standard of Care (Kaletra in Combination With 2 Nucleoside RTIs) in naïve-HIV-1 Positive Patients
- ClinicalTrials.gov ID
- NCT00234910
- Acronym / sponsor ID
- KALEAD / ITAL-04-002
- Conditions
- HIV Infection
- Keywords
- Lopinavir, Ritonavir, Kaletra, Tenofovir, HIV infection, Treatment Naive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2008 (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 obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Tenofovir DF, Drug: lopinavir/ritonavir with 2 Nucleoside RTIs2 drug arm |
| B | Active comparator | Drug: lopinavir/ritonavir with 2 Nucleoside RTIs3 drug arm, SOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV positive
- >18 years of age
- HIV RNA> 400 copies/mL
- Any CD 4 cell count
- Antiretroviral naïve
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 |
|---|---|---|
| Tenofovir DFTDF 300mg QD for 72 wks | Drug | A |
| lopinavir/ritonavir with 2 Nucleoside RTIsAlso: ABT-378, Kaletra, lopinavir/ritonavirLPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks | Drug | A, B |
Primary outcome
Antiviral efficacy by HIV RNA
Time frame: 72 wks
Incidence of adverse events
Time frame: 72 wks
1 secondary outcome
Adherence and quality of life
Time frame: 72 wks
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 10 Jul 2008.
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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.
Umberto di Luzio Paparatti, MD 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 3 study testing Tenofovir DF and lopinavir/ritonavir with 2 Nucleoside RTIs 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 6 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 10 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Antiviral efficacy by HIV RNA (time frame: 72 wks). 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 10 Jul 2008.