HIV InfectionsPhase 4KITENCT00700115

Kaletra-isentress Treatment Evaluation

A Phase 4 study testing Kaletra + Isentress and Pre-study antiretroviral regimen in people with HIV Infections, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Kaletra + Isentress and Pre-study antiretroviral regimen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Jun 2008to Jan 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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-1-infected individuals receiving HAART regimen (if on PI-based regimen, must be 1st PI-containing HAART).
They must have been on and tolerating current HAART regimen for > 6-months.
Plasma HIV-1 viral load < 50 copies/ml at study entry.
Men and women age > 18 years (sex is defined as sex at birth).
Laboratory values obtained within 30 days prior to study entry:
Hemoglobin > 9.4 g/dl

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Creatinine < 2 mg/dl
AST (SGOT) < 2 x ULN
ALT (SGPT) < 2 x ULN
Ability and willingness of subject or legal guardian/representative to give written informed consent.
No CD4 T-cell counts requirement

Who cannot join

Subjects with a history of previous intolerance to or virological failure to LPV/r
Concomitant drugs (including alternative therapies) that may affect PI or RAL plasma concentrations (inducers or inhibitors of the CYP 3A4 or UDP-glucuronosyltransferase iso-enzymes).
A known history of noncompliance with medications or a known history of noncompliance with scheduled physician and clinic visits.
Investigational ARV drug.
Pregnancy/Breast feeding.
HBV-coinfected patients receiving nucleoside analogue for both HIV and HBV suppression.
Active drug or alcohol use or dependence which, in the Investigator's opinion, may interfere with adherence to study requirements or endanger subject's health while on the study.
Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to the screening visit.

Trial locations and contacts

1 site in 1 country.

United States1 site

Grady Infectious Diseases Program (Ponce Clinic)
Atlanta, Georgia, 30308

Other trials in United States

About this study

Official title: A Pilot Study to Assess the Safety, Efficacy, and PK Profile of a Switch in Antiretroviral Therapy to a RTI Sparing Combination of LPV/r and RAL in Virologically Suppressed HIV-infected Patients

This study will examine the effectiveness and safety of raltegravir (isentress) when used together with lopinavir/ritonavir (kaletra) for the treatment of HIV-infection. Isentress is a recently, Food and Drug Administration (FDA) approved, HIV medication that has strong effects against the HIV virus. Isentress has been shown in other studies to be safe and well tolerated by HIV patients. Combining this drug with kaletra might enable us to construct a HIV regimen that does not include the more toxic drugs of the nucleoside reverse transcriptase inhibitor class.

Eligible volunteers will undergo the following as part of the study procedure:

Sign the study consent form and the HIPAA Authorization Form.
Two-third of subjects, the intervention group (selected by random chance) will have their HIV drug treatment changed to kaletra + isentress.
The other one-third will continue their usual HIV medications (this will be the control group).
Make 9 study related visits to the Ponce clinic during the 48 weeks study period. During these visits, medical information will be collected, and blood tests will be performed.
Perform Dexa-scan on two separate occasions at Emory University Hospital Radiology.

Information collected will be used to assess the effectiveness of this treatment in keeping the HIV virus suppressed, how well these two drugs together is tolerated by HIV-infected patients, and the blood levels of these two drugs when given together.

Read the detailed description

RATIONALE: Virologic failure and adverse effects associated with current highly active antiretroviral therapy (HAART) warrant continuing search for novel combination therapeutic options. Raltegravir's (RAL) was recently shown to be a potent antiretroviral (ARV) agent with a favorable safety profile. If future reports continue to show positive data on this first-in-class integrase inhibitor, there may be a paradigm shift in the currently recommended first line HAART to regimens that will include integrase inhibitors.

Combining RAL with a drug that has a high genetic barrier to resistance, such as lopinavir/ritonavir (LPV/r) may offer a number of advantages. Both agents are potent and should produce durable virologic suppression. Because their combination is reverse transcriptase inhibitor (RTI) class sparing, its tolerability might be superior. In addition, RAL is not metabolized by the cytochrome P-450 enzymes, therefore, a compatible pharmacokinetic profile is expected with this combination. Pairing LPV/r with RAL in early ARV regimens as is proposed in this application may provide a HAART regimen that is highly efficacious and durable, with less resistance and adverse drug events.

DESIGN: This is single center, open label, randomized, controlled, study designed to assess the tolerability, pharmacokinetic compatibility, and the durability of virologic suppression of the RTI sparing combination therapy of LPV/r + RAL. HIV-infected subjects who are virologically suppressed (HIV-RNA PCR < 50 copies/ml) on current HAART regimen will be randomized in a 2:1 fashion to be switched to a regimen consisting of LPV/r + RAL, intervention arm A (n=40), or to be continued on their pre-study HAART regimen, control arm B (n=20). The primary endpoint will be proportion of subjects with sustained virologic suppression (HIV-1 RNA PCR < 50 copies/ml) through week 48. The immunoreconstitution, toxicity profile, and pharmacokinetic profile of the RAL and LPV/r in this novel combination therapy will be evaluated.

DURATION: 48 weeks after the enrollment of the last participant. Enrollment is expected to take about 10 months.

SAMPLE SIZE: 60 subjects.

POPULATION: HIV-infected individuals (male and female), Age > 18 years, who are virologically suppressed (HIV-RNA PCR < 50 copies/ml) on their current HAART regimen for > 6 months.

REGIMEN: For Arm A= LPV/r 400/100 mg (2 tablets) twice daily + RAL 400 mg (1 tablet) twice daily taken by mouth. For Arm B=Pre-study HAART regimen.

Conditions: HIV Infections
Being tested: Kaletra + Isentress, Pre-study antiretroviral regimen
Keywords: HAART, lopinavir/ritonavir, raltegravir, HIV/AIDS patients on HAART, Treatment Experienced
Medical subject headings: HIV Infections

What participants receive

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

Kaletra + IsentressDrug
Also called Raltegravir, Lopinavir/ritonavir
Kaletra 400/100 mg + Isentress 400 mg BID
Pre-study antiretroviral regimenDrug
Also called HAART
Standard doses of pre-study antiretroviral regimen

Study groups in NCT00700115
Study group	Role	What they receive
Kaletra + Isentress	Experimental	Kaletra + Isentress Receives: Drug: Kaletra + Isentress
Standard HAART	Active comparator	Pre-study Antiretroviral regimen Receives: Drug: Pre-study antiretroviral regimen

What is being measured

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

Plasma Viral Loads (HIV-1 RNA PCR)
Percentage subjects with undetectable Plasma viral loads
Measured: baseline to week 48

Secondary outcomes (1)

To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects
Measured: 48 weeks

Timeline

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

Jun 2008Jan 2011

First posted18 Jun 2008 (estimated)
Study startJun 2008
Primary completionJan 2011
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Emory UniversityThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00700115
Sponsor's protocol ID: IRB00006876
Other IDs: KITE-6876
Acronym: KITE
Status last verified: Nov 2014
First submitted: 16 Jun 2008
Last updated: 12 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ofotokun I, Sheth AN, Sanford SE, Easley KA, Shenvi N, White K, Eaton ME, Del Rio C, Lennox JL. A switch in therapy to a reverse transcriptase inhibitor sparing combination of lopinavir/ritonavir and raltegravir in virologically suppressed HIV-infected patients: a pilot randomized trial to assess efficacy and safety profile: the KITE study. AIDS Res Hum Retroviruses. 2012 Oct;28(10):1196-206. doi: 10.1089/AID.2011.0336. Epub 2012 Apr 20.
PubMed 22364141

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

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Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study to Assess the Safety, Efficacy, and PK Profile of a Switch in Antiretroviral Therapy to a RTI Sparing Combination of LPV/r and RAL in Virologically Suppressed HIV-infected Patients
ClinicalTrials.gov ID: NCT00700115
Acronym / sponsor ID: KITE / IRB00006876
Conditions: HIV Infections
Keywords: HAART, lopinavir/ritonavir, raltegravir, HIV/AIDS patients on HAART, Treatment Experienced
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: Abbott, Merck Sharp & Dohme LLC
Study start: Jun 2008
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 18 Jun 2008 (estimated)
Results: Posted 22 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Eligible volunteers will undergo the following as part of the study procedure:

Sign the study consent form and the HIPAA Authorization Form.
Two-third of subjects, the intervention group (selected by random chance) will have their HIV drug treatment changed to kaletra + isentress.
The other one-third will continue their usual HIV medications (this will be the control group).
Make 9 study related visits to the Ponce clinic during the 48 weeks study period. During these visits, medical information will be collected, and blood tests will be performed.
Perform Dexa-scan on two separate occasions at Emory University Hospital Radiology.

Detailed description

DURATION: 48 weeks after the enrollment of the last participant. Enrollment is expected to take about 10 months.

SAMPLE SIZE: 60 subjects.

POPULATION: HIV-infected individuals (male and female), Age > 18 years, who are virologically suppressed (HIV-RNA PCR < 50 copies/ml) on their current HAART regimen for > 6 months.

REGIMEN: For Arm A= LPV/r 400/100 mg (2 tablets) twice daily + RAL 400 mg (1 tablet) twice daily taken by mouth. For Arm B=Pre-study HAART regimen.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Kaletra + Isentress	Experimental	Drug: Kaletra + IsentressKaletra + Isentress
Standard HAART	Active comparator	Drug: Pre-study antiretroviral regimenPre-study Antiretroviral regimen

Who may qualify

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

Key inclusion criteria (11 listed)

HIV-1-infected individuals receiving HAART regimen (if on PI-based regimen, must be 1st PI-containing HAART).
They must have been on and tolerating current HAART regimen for > 6-months.
Plasma HIV-1 viral load < 50 copies/ml at study entry.
Men and women age > 18 years (sex is defined as sex at birth).
Laboratory values obtained within 30 days prior to study entry:

Key exclusion criteria (8 listed)

Subjects with a history of previous intolerance to or virological failure to LPV/r
Concomitant drugs (including alternative therapies) that may affect PI or RAL plasma concentrations (inducers or inhibitors of the CYP 3A4 or UDP-glucuronosyltransferase iso-enzymes).
A known history of noncompliance with medications or a known history of noncompliance with scheduled physician and clinic visits.
Investigational ARV drug.
Pregnancy/Breast feeding.

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
Kaletra + IsentressAlso: Raltegravir, Lopinavir/ritonavirKaletra 400/100 mg + Isentress 400 mg BID	Drug	Kaletra + Isentress
Pre-study antiretroviral regimenAlso: HAARTStandard doses of pre-study antiretroviral regimen	Drug	Standard HAART

Primary outcome

Plasma Viral Loads (HIV-1 RNA PCR)
Time frame: baseline to week 48
Percentage subjects with undetectable Plasma viral loads

1 secondary outcome

To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects
Time frame: 48 weeks

Results and safety

Results posted to the registry on 22 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Kaletra + Isentress	40	39
Standard HAART	20	19

Primary outcome: Plasma Viral Loads (HIV-1 RNA PCR)

Time frame: baseline to week 48. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Kaletra + Isentress n = 40	Standard HAART n = 20
Value	92.7 (83 to 100)	88 (75 to 100)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Kaletra + Isentress	0 of 39 (0%)	0 of 39 (0%)	Not reported
Standard HAART	0 of 19 (0%)	0 of 19 (0%)	Not reported

Limitations and caveats (from the sponsor): The findings of the KITE study should be interpreted in the context of a pilot study with a small sample size. Furthermore, adverse effects were self-reported, and the lack of blinding may have introduced biases in the collection of the data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22364141Ofotokun I, Sheth AN, Sanford SE, Easley KA, Shenvi N, White K, Eaton ME, Del Rio C, Lennox JL. A switch in therapy to a reverse transcriptase inhibitor sparing combination of lopinavir/ritonavir and raltegravir in virologically suppressed HIV-infected patients: a pilot randomized trial to assess efficacy and safety profile: the KITE study. AIDS Res Hum Retroviruses. 2012 Oct;28(10):1196-206. doi: 10.1089/AID.2011.0336. Epub 2012 Apr 20.

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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.

Igho Ofotokun, MD, MSc principal investigator

Emory University

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 Kaletra + Isentress and Pre-study antiretroviral regimen in people with HIV Infections, run by Emory University 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 11 inclusion and 8 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 12 Dec 2014. 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?

Yes. Results are posted in the registry (first posted 22 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Plasma Viral Loads (HIV-1 RNA PCR) (time frame: baseline to week 48). 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 NCT00700115, which also lists 1 linked publication.

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 12 Dec 2014; AzTrials last refreshed its copy on 6 Nov 2026.