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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Therapeutic Concepts.
Recruitment status was  Recruiting
Tibotec, Inc
Information provided by:
Therapeutic Concepts
ClinicalTrials.gov Identifier:
First received: January 8, 2010
Last updated: February 12, 2010
Last verified: January 2010
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 Intervention Phase
HIV Infections
Drug: Kaletra and Intelence Tablets
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IV 48 Week, Open Label, Pilot Study of Kaletra and Intelence Tablets in Naive Subjects

Resource links provided by NLM:

Further study details as provided by Therapeutic Concepts:

Primary Outcome Measures:
  • Proportion of patients with plasma HIV-1 RNA < 400 copies/mL at weeks 24 and 48 [ Time Frame: At weeks 24 and 48 ] [ Designated as safety issue: Yes ]
  • Proportion of patients with plasma HIV-1 RNA < 75 copies/mL at weeks 24 and 48 [ Time Frame: At weeks 24 and 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Number of weeks until HIV RNA < 400 copies/mL and < 75 copies/mL, respectively [ Time Frame: At weeks 24 and 48 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045369

Contact: Bernie A Miguel (713) 526- 9821 research@josephgathe.com

United States, Texas
Therapeutic Concepts, PA Recruiting
Houston, Texas, United States, 77004
Contact: Bernie A. Miguel    713-526-9821    research@josephgathe.com   
Principal Investigator: Joseph C. Gathe, Jr., MD         
Sponsors and Collaborators
Therapeutic Concepts
Tibotec, Inc
Principal Investigator: Joseph C. Gathe, Jr., MD Therapeutic Concepts
  More Information

Responsible Party: Joseph C. Gathe, Jr., MD, Therapeutic Concepts, PA
ClinicalTrials.gov Identifier: NCT01045369     History of Changes
Other Study ID Numbers: 101-001 
Study First Received: January 8, 2010
Last Updated: February 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Therapeutic Concepts:
Treatment Naive

Additional relevant MeSH terms:
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Protease Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016