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A Pilot Study of Kaletra and Intelence Tablets in Naive Subjects (KALYINTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01045369
Recruitment Status : Completed
First Posted : January 11, 2010
Last Update Posted : May 1, 2017
Tibotec, Inc
Information provided by (Responsible Party):
Joseph Gathe Jr. M.D., Therapeutic Concepts

Brief Summary:
The purpose of this study is to see if using a combination of other drug classes, like the ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV in your blood. Using Kaletra® and Intelence™ without other drugs is not approved by the FDA and so their use in this study is experimental.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Kaletra and Intelence Tablets Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV 48 Week, Open Label, Pilot Study of Kaletra and Intelence Tablets in Naive Subjects
Study Start Date : January 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Kaletra And Intelence
This is a Phase IV, 48-week, open-label, pilot study in 30 ARV-naïve patients examining the safety, viral response, and tolerability of Kaletra® and Intelence™ tablets.
Drug: Kaletra and Intelence Tablets
Kaletra 400 mg twice a day and Intelence Tablets 200mg twice a day.

Primary Outcome Measures :
  1. Proportion of patients with plasma HIV-1 RNA < 400 copies/mL at weeks 24 and 48 [ Time Frame: At weeks 24 and 48 ]
  2. Proportion of patients with plasma HIV-1 RNA < 75 copies/mL at weeks 24 and 48 [ Time Frame: At weeks 24 and 48 ]

Secondary Outcome Measures :
  1. Proportion of patients with plasma HIV-1 RNA < 400 copies/mL or < 75 copies/mL at each study visit [ Time Frame: At weeks 24 and 48 ]
  2. Number of weeks until HIV RNA < 400 copies/mL and < 75 copies/mL, respectively [ Time Frame: At weeks 24 and 48 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV-1 RNA ≥ 5000 copies/mL by Roche Amplicor 1.5v Primer
  • More than 18 years of age
  • Provide written informed consent and willingness to participate in and comply
  • Less than 7 days of prior ART with any licensed or investigational compound
  • Does not currently have or has not been treated for an active opportunistic infection (OI) within 30 days of screening
  • Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness
  • A female who is a non-childbearing potentiator or if in child-bearing potential, has a negative serum pregnancy test at screen and agrees to one of the following: complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for at least 2 weeks after completion or premature discontinuation from the study to account for elimination of the investigational drug. Should a patient decide to become sexually active during the course of the study, she must be counseled and be willing to use one of the birth control methods like double barrier method, intrauterine device, sterilization and any other methods.

NOTE: Data are insufficient to exclude a clinically important interaction of LPV/r with drugs, such as hormonal contraceptives, that are highly metabolized by the cytochrome P450 enzyme system. As a result, hormonal contraception is not considered adequate.

Exclusion Criteria:

  • Patient with active AIDS-defining opportunistic infection in the 30 days prior to baseline and that, in the opinion of the investigator, would preclude the patient from participating in the study (See Appendix C).
  • Patient has a weighted genotypic score for etravirine ≥3 . (See Appendix D)
  • Patient has >3 mutations at 10, 20, 24, 32, 33, 36, 46, 47, 48, 50, 54, 73, 82, 84, or 90 in protease or ≥1 of the following mutations in protease (I47A/V, V32I, or L76V).
  • History of active substance abuse.
  • Pregnant at time of screening evaluation or breast-feeding.
  • Patient, in the opinion of the investigator, is unlikely to be able to complete the 48-week dosing period and protocol evaluations and assessments or adhere to the study drug regimen.
  • Serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the patient
  • Malabsorption syndrome or other gastrointestinal dysfunction, which may interfere with drug absorption or render the patient unable to take oral medication.
  • Undergoing interferon therapy for HCV or anticipates undergoing therapy during the course of this trial
  • HBV co-infection
  • Laboratory results within 30 days prior to the first dose of study medication:

    • Hemoglobin concentration < 8.0 g/dL
    • Absolute neutrophil count < 750 cells/mm3
    • Platelet count <50,000 cells/ mm3
    • Aminotransferase (AST, ALT) >3 times ULN
    • Serum creatinine >1.5 times the Upper Limits of Normal (ULN)
  • Radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to entry, or has an anticipated need for these agents within the study period.
  • Immunomodulating agents, such as systemic corticosteroids, interleukins, or interferon's within 4 weeks prior to study entry, or patients who have received an HIV immunotherapeutic vaccine within 3 months prior to entry. Asthmatic patients using inhaled corticosteroids are eligible for enrollment.
  • Methadone therapy
  • Foscarnet therapy or therapy with other agents with documented activity against HIV-1 in vitro.
  • Taking astemizole, terfenadine, cisapride, oral midazolam, triazolam, flecainide, pimozide, propafenone, St. John's Wort, lovastatin, simvastatin, and rifampin or ergot derivatives.
  • Allergy to any of the study drugs or any excipients therein.
  • Patient requires inhaled or intranasal fluticasone.

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 identifier (NCT number): NCT01045369

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United States, Texas
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
Sponsors and Collaborators
Therapeutic Concepts
Tibotec, Inc
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Principal Investigator: Joseph C. Gathe, Jr., MD Therapeutic Concepts
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Responsible Party: Joseph Gathe Jr. M.D., MD, Therapeutic Concepts Identifier: NCT01045369    
Other Study ID Numbers: 101-001
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: January 2010
Keywords provided by Joseph Gathe Jr. M.D., Therapeutic Concepts:
Treatment Naive
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors