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Kaletra and Viread in Antiretroviral Naïve Patients

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.
 
ClinicalTrials.gov Identifier: NCT00679926
Recruitment Status : Terminated (Lack of enrollment)
First Posted : May 19, 2008
Last Update Posted : October 10, 2012
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Johnny Stephens, Oklahoma State University Center for Health Sciences

Tracking Information
First Submitted Date  ICMJE May 15, 2008
First Posted Date  ICMJE May 19, 2008
Last Update Posted Date October 10, 2012
Study Start Date  ICMJE May 2008
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2008)
To assess the efficacy of once daily antiretroviral therapy with Viread 300mg and Kaletra 800mg/200mg in suppressing HIV RNA levels to <50 copies/ml in antiretroviral naïve patients. [ Time Frame: 4, 8, 12, 16, 24, 32, 40, and 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2008)
  • Proportion of patients with <400copies/ml [ Time Frame: 4,8, and 12 weeks ]
  • Review virologic response to assess rate of viral decline. [ Time Frame: weeks 4, 8, 12, 16, and 24 ]
  • Proportion of patients with <50 copies/ml HIV-1 RNA [ Time Frame: at weeks 4, 8, 12, 16, 24, 32, 40, and 48 ]
  • Change from baseline CD4 counts [ Time Frame: at weeks 4, 8, 12, 16, 24, 32, 40, and 48 ]
  • Time to virologic failure. [ Time Frame: Week 48 ]
  • Tolerability and adverse events. [ Time Frame: 48 weeks ]
  • Change from baseline fasting total cholesterol and fasting triglyceride levels. [ Time Frame: 48 weeks ]
  • Characterize adherence rates for this therapeutic regimen by the use of Medication Electronic Monitoring Systems (MEMS) caps. [ Time Frame: 48 weeks ]
  • Characterize adherence rates for this therapeutic regimen by use of pharmacy refill records. [ Time Frame: 48 weeks ]
  • Assess genotypic changes in patients with virologic failure. [ Time Frame: 48 weeks ]
  • Assess lopinavir trough levels in patients failing to obtain virologic suppression. [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Kaletra and Viread in Antiretroviral Naïve Patients
Official Title  ICMJE A Phase IV Open Label Investigation of the Efficacy and Durability of Once Daily Antiretroviral Therapy With Kaletra and Viread in Antiretroviral Naïve Patients.
Brief Summary Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r, 800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to <50 copies/ml in antiretroviral naïve patients through 48 weeks of therapy.
Detailed Description

This study is a phase IV prospective, open-label, controlled treatment protocol consisting of once daily Kaletra dosed at 800mg lopinavir with 200mg ritonavir in four combination tablets plus Viread dosed as 300 mg tenofovir DF. This will be a single site, multi-investigator, study for 48 weeks. Consecutive eligible patients will be enrolled into the study to reach the enrollment goal of 30 patients. Eligible patients will be identified and screened during routine initial or follow-up visits at the Internal Medicine Specialty Services Clinic. This clinic serves as the HIV/AIDS specialty care clinic and is a subdivision of the Department of Internal Medicine, Oklahoma State University Center for Health Sciences College of Osteopathic Medicine. The study site currently serves >700 persons living with HIV in northeast Oklahoma with four to five antiretroviral naïve patients seen each week.

Patients meeting all inclusion criteria will receive routine standard of care for our program as prescribed by the DHHS guidelines. Patients will have a Complete Blood Count (CBC), Complete Metabolic Profile (CMP), fasting lipid profile, CD4 count, HIV-1 RNA level, and other prescribed or indicated laboratory preformed at baseline and throughout the study as described in the Visits and Evaluations section of this protocol. All of the aforementioned laboratory tests will be performed at the Diagnostic Laboratories of Oklahoma, a division of Quest Diagnostics. Any antiretroviral resistance testing will be performed at Virologic Labs, Inc. Adherence will be assessed at discontinuation of the study and when indicated for evaluation of virologic failure by Memory Electronic Monitoring Systems caps and pharmacy refill data. Patients will be monitored at each study visit for tolerability and adverse events. Patients who develop a study related Grade 1 or 2 Adverse Events (Aes) may continue the study. Those who develop Grade 3 or 4 AEs will have study medications discontinued. Patients with asymptomatic elevations of triglyceride or Low Density Lipoprotein (LDL) cholesterol levels may be treated with appropriate lipid lowering therapy at the investigators discretion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE Drug: Lopinavir/ritonavir and tenofovir
Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily
Other Names:
  • Kaletra
  • Viread
Study Arms  ICMJE Experimental: 1
Patients taking lopinavir/ritonavir and tenofovir once daily.
Intervention: Drug: Lopinavir/ritonavir and tenofovir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 9, 2012)
6
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2008)
30
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients >18 years of age with documented HIV-1 infection
  2. Naïve to antiretroviral therapy
  3. Able and willing to provide written informed consent
  4. No CD4 restriction
  5. HIV-1 RNA levels >5000 c/mL
  6. Female patients must meet these additional criteria

    1. Non-childbearing potential
    2. Negative serum pregnancy test at screen
    3. Willingness to abstain from sexual intercourse or use double barrier contraception

Exclusion Criteria:

  1. Presence of any of the following:

    1. Aminotransferases >3xULN
    2. Hemoglobin concentration <8.0g/dl
    3. Absolute neutrophil count <800 cells/cubic mm
    4. Platelet count <50,000 cells/cubic mm
    5. Acute illness, or an acute illness ≤7 days
    6. Presence of Opportunistic Infection, or an OI within 30 days of screening
    7. Acute or chronic active Hepatitis B
    8. Hepatitis C
    9. Creatinine Clearance <50 mL/min
  2. Pregnant or breast-feeding women
  3. Presence of any illness, physical or behavioral conditions (i.e., substance abuse, excluding cannabis) that will impair the patient's ability participate
  4. Patient who, in the opinion of the investigator, will be unlikely to complete the study protocol and adhere to the study drug regimens
  5. Concurrent use of medications that may potentially interact with study medications including: astemizole, terfenadine, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's wort, lovastatin, simvastatin, pimozide, midazolam, triazolam, adefovir, cidofovir, acyclovir, ganciclovir, and valganciclovir.
  6. Patient suffers from a serious medical condition that may in the opinion of the investigator compromise his or her safety.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00679926
Other Study ID Numbers  ICMJE Baker - 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnny Stephens, Oklahoma State University Center for Health Sciences
Study Sponsor  ICMJE Oklahoma State University Center for Health Sciences
Collaborators  ICMJE Abbott
Investigators  ICMJE
Principal Investigator: Damon Baker, D.O. Oklahoma State University Center for Health Sciences
PRS Account Oklahoma State University Center for Health Sciences
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP