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Kaletra-isentress Treatment Evaluation (KITE)

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ClinicalTrials.gov Identifier: NCT00700115
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : October 22, 2013
Last Update Posted : December 12, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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:

  1. Sign the study consent form and the HIPAA Authorization Form.
  2. Two-third of subjects, the intervention group (selected by random chance) will have their HIV drug treatment changed to kaletra + isentress.
  3. The other one-third will continue their usual HIV medications (this will be the control group).
  4. 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.
  5. 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.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: Kaletra + Isentress Drug: Pre-study antiretroviral regimen Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2008
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Kaletra + Isentress
Kaletra + Isentress
Drug: Kaletra + Isentress
Kaletra 400/100 mg + Isentress 400 mg BID
Other Names:
  • Raltegravir
  • Lopinavir/ritonavir
Active Comparator: Standard HAART
Pre-study Antiretroviral regimen
Drug: Pre-study antiretroviral regimen
Standard doses of pre-study antiretroviral regimen
Other Name: HAART


Outcome Measures

Primary Outcome Measures :
  1. Plasma Viral Loads (HIV-1 RNA PCR) [ Time Frame: baseline to week 48 ]
    Percentage subjects with undetectable Plasma viral loads


Secondary Outcome Measures :
  1. To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects [ Time Frame: 48 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700115


Locations
United States, Georgia
Grady Infectious Diseases Program (Ponce Clinic)
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
Abbott
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Igho Ofotokun, MD, MSc Emory University
More Information

Publications:
Responsible Party: Ighovwerha Ofotokun, Associate Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT00700115     History of Changes
Other Study ID Numbers: IRB00006876
KITE-6876 ( Other Identifier: Other )
First Posted: June 18, 2008    Key Record Dates
Results First Posted: October 22, 2013
Last Update Posted: December 12, 2014
Last Verified: November 2014

Keywords provided by Ighovwerha Ofotokun, Emory University:
HAART
lopinavir/ritonavir
raltegravir
HIV/AIDS patients on HAART
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Lopinavir
Raltegravir Potassium
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors