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

A Phase IV 48 Week, Open Label, Pilot Study of Kaletra and Intelence Tablets in Naive Subjects

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Kaletra and Intelence Tablets

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77004
      • Therapeutic Concepts, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with plasma HIV-1 RNA < 400 copies/mL at weeks 24 and 48	At weeks 24 and 48
Proportion of patients with plasma HIV-1 RNA < 75 copies/mL at weeks 24 and 48	At weeks 24 and 48

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Therapeutic Concepts
• Collaborators: Abbott; Tibotec, Inc; BluKyne
• Investigators: Principal Investigator: Joseph C. Gathe, Jr., MD, Therapeutic Concepts

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 8, 2010
• First Posted (ESTIMATE): January 11, 2010

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: HIV; Treatment Naive
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Etravirine
• Other Study ID Numbers: 101-001