HIV InfectionsPhase 4NCT00414284
BOOST: Study of Increased Dosage of Lopinavir/Ritonavir (LPV/r)
A Phase 4 study testing Increased dose of Kaletra in people with HIV Infections, run by Community Research Initiative of New England at 1 site in United States.
Trial summary
This study will look to see if increasing the standard dose of Kaletra is tolerated and if it will lower viral loads to undetectable levels. This study will also look at the pharmacokinetic data (amount of Kaletra in blood at different times). 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?
- Increased dose of Kaletra
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Apr 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
- Adult, Older adult
Who may be able to join
- CD4 Count >50
- Viral load 200-75,000 on two most recent measures
- More than 16 weeks on standard dose Kaletra (LPV/r)
- May be initial PI regimen or prior PI usage
- Up to 50-fold resistance to LPV/r
Who cannot join
- Age < 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Research Initiative of New England - Boston
Boston, Massachusetts, 02215
About this study
Official title: Evaluation of the Pharmacokinetics and Tolerability of Increased Dosage of Lopinavir/Ritonavir(LPV/r) in Individuals Experiencing Viremia on Standard Dose LPV/r Using LPV/r Tablet Formulation
This study will look to see if increasing the standard dose of Kaletra is tolerated and if it will lower viral loads to undetectable levels. This study will also look at the pharmacokinetic data (amount of Kaletra in blood at different times).
Read the detailed description
There are several reasons for low level viremia in patients on Kaletra (LPV/r), including poor adherence, incomplete absorption, cellular drug pumps or resistance mutations. Increasing exposure to protease inhibitors via boosting with ritonavir increases minimum blood concentrations, and is a strategy which has been shown to improve suppression of virologic replication. Little is known about the pharmacokinetics (PK), tolerability and safety of increased doses of LPV/r. The objectives of this 24-week single arm pilot study are to assess the PK parameters, safety, tolerability, change in viral load and CD4 counts on increased dose (600/150 and 800/200 mg) LPV/r in participants with low level viremia on standard dose LPV/r-based ART. Participants will undergo six PK samplings over 12 hours on standard dose LPV/r. The dose will be increased to 3 tabs (600/150) BID and blood will be sampled for PK after two weeks. If tolerated at 8 weeks, the dose will be increased to 4 tabs (800/200 mg) BID and final PK sampling will be performed after two weeks. There will be a one time, optional, optimization of background regimen of NRTIs two weeks after the first dose escalation.
Major Eligibility Criteria:
- CD4 count: > 50
- Viral load: 200-75,000 on two most recent measures
- Current treatment: > 16 weeks standard dose (400/100mg BID) LPV/r-based ART (no other PI or NNRTI allowed
- Prior treatment experience and resistance profile: Up to 20-fold resistance to LPV/r
- Conditions
- HIV Infections
- Being tested
- Increased dose of Kaletra
- Keywords
- HIV/AIDS, viremia, Kaletra, pharmacokinetics, viral load, LPV/r, Treatment Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Viremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased dose of KaletraDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacokinetic parameters of higher doses of LPV/r
Secondary outcomes (3)
To evaluate plasma HIV-1 RNA change after increasing the dose of LPV/r
To evaluate change in CD4 count after increased dose LPV/r
To compare the tolerability and laboratory safety profile of LPV/r 3 and 4 tablets BID
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startJun 2006
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: One subject's HIV RNA rebounded at week 12. A repeat PhenoSense GT combination resistance assay at week 12 revealed evolution in protease inhibitor resistance.
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.
- 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
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Community Research Initiative of New England
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Investigators
- Calvin J Cohen, MD, MSc, Principal investigator, CRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414284
- Sponsor's protocol ID
- 06-124
- Other IDs
- IND #71128
- Status last verified
- Dec 2010
- First submitted
- 20 Dec 2006
- Last updated
- 8 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetics and Tolerability of Increased Dosage of Lopinavir/Ritonavir(LPV/r) in Individuals Experiencing Viremia on Standard Dose LPV/r Using LPV/r Tablet Formulation
- ClinicalTrials.gov ID
- NCT00414284
- Acronym / sponsor ID
- 06-124
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, viremia, Kaletra, pharmacokinetics, viral load, LPV/r, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: One subject's HIV RNA rebounded at week 12. A repeat PhenoSense GT combination resistance assay at week 12 revealed evolution in protease inhibitor resistance.
- Lead sponsor
- Community Research Initiative of New EnglandUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jun 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 21 Dec 2006 (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.
This study will look to see if increasing the standard dose of Kaletra is tolerated and if it will lower viral loads to undetectable levels. This study will also look at the pharmacokinetic data (amount of Kaletra in blood at different times).
Detailed description
There are several reasons for low level viremia in patients on Kaletra (LPV/r), including poor adherence, incomplete absorption, cellular drug pumps or resistance mutations. Increasing exposure to protease inhibitors via boosting with ritonavir increases minimum blood concentrations, and is a strategy which has been shown to improve suppression of virologic replication. Little is known about the pharmacokinetics (PK), tolerability and safety of increased doses of LPV/r. The objectives of this 24-week single arm pilot study are to assess the PK parameters, safety, tolerability, change in viral load and CD4 counts on increased dose (600/150 and 800/200 mg) LPV/r in participants with low level viremia on standard dose LPV/r-based ART. Participants will undergo six PK samplings over 12 hours on standard dose LPV/r. The dose will be increased to 3 tabs (600/150) BID and blood will be sampled for PK after two weeks. If tolerated at 8 weeks, the dose will be increased to 4 tabs (800/200 mg) BID and final PK sampling will be performed after two weeks. There will be a one time, optional, optimization of background regimen of NRTIs two weeks after the first dose escalation.
Major Eligibility Criteria:
- CD4 count: > 50
- Viral load: 200-75,000 on two most recent measures
- Current treatment: > 16 weeks standard dose (400/100mg BID) LPV/r-based ART (no other PI or NNRTI allowed
- Prior treatment experience and resistance profile: Up to 20-fold resistance to LPV/r
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CD4 Count >50
- Viral load 200-75,000 on two most recent measures
- More than 16 weeks on standard dose Kaletra (LPV/r)
- May be initial PI regimen or prior PI usage
- Up to 50-fold resistance to LPV/r
Key exclusion criteria (1 listed)
- Age < 18 years old
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 |
|---|---|---|
| Increased dose of Kaletra | Drug | – |
Primary outcome
To evaluate the pharmacokinetic parameters of higher doses of LPV/r
3 secondary outcomes
To evaluate plasma HIV-1 RNA change after increasing the dose of LPV/r
To evaluate change in CD4 count after increased dose LPV/r
To compare the tolerability and laboratory safety profile of LPV/r 3 and 4 tablets BID
Results and safety
The study was stopped early (reason given: One subject's HIV RNA rebounded at week 12. A repeat PhenoSense GT combination resistance assay at week 12 revealed evolution in protease inhibitor resistance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2010.
- Web page of CRI, the nonprofit research group sponsoring the studyLink 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.
Calvin J Cohen, MD, MSc principal investigator
CRI
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 Increased dose of Kaletra in people with HIV Infections, run by Community Research Initiative of New England 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 5 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 8 Dec 2010. 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 (reason given: One subject's HIV RNA rebounded at week 12. A repeat PhenoSense GT combination resistance assay at week 12 revealed evolution in protease inhibitor resistance.). 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?
To evaluate the pharmacokinetic parameters of higher doses of LPV/r. 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 8 Dec 2010; AzTrials last refreshed its copy on 8 Nov 2026.