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Kaletra and Viread in Antiretroviral Naïve Patients

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Lopinavir/ritonavir and tenofovir Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV Open Label Investigation of the Efficacy and Durability of Once Daily Antiretroviral Therapy With Kaletra and Viread in Antiretroviral Naïve Patients.
Study Start Date : May 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Patients taking lopinavir/ritonavir and tenofovir once daily.
 Drug: Lopinavir/ritonavir and tenofovir
Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily
Other Names:
  • Kaletra
  • Viread


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Proportion of patients with <400copies/ml [ Time Frame: 4,8, and 12 weeks ]
  2. Review virologic response to assess rate of viral decline. [ Time Frame: weeks 4, 8, 12, 16, and 24 ]
  3. Proportion of patients with <50 copies/ml HIV-1 RNA [ Time Frame: at weeks 4, 8, 12, 16, 24, 32, 40, and 48 ]
  4. Change from baseline CD4 counts [ Time Frame: at weeks 4, 8, 12, 16, 24, 32, 40, and 48 ]
  5. Time to virologic failure. [ Time Frame: Week 48 ]
  6. Tolerability and adverse events. [ Time Frame: 48 weeks ]
  7. Change from baseline fasting total cholesterol and fasting triglyceride levels. [ Time Frame: 48 weeks ]
  8. Characterize adherence rates for this therapeutic regimen by the use of Medication Electronic Monitoring Systems (MEMS) caps. [ Time Frame: 48 weeks ]
  9. Characterize adherence rates for this therapeutic regimen by use of pharmacy refill records. [ Time Frame: 48 weeks ]
  10. Assess genotypic changes in patients with virologic failure. [ Time Frame: 48 weeks ]
  11. Assess lopinavir trough levels in patients failing to obtain virologic suppression. [ Time Frame: 48 weeks ]

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

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00679926


Locations
United States, Oklahoma
OSU Internal Medicine Specialty Clinic
Tulsa, Oklahoma, United States, 74127
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Abbott
Investigators
Principal Investigator: Damon Baker, D.O. Oklahoma State University Center for Health Sciences
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Johnny Stephens, Associate Professor, Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT00679926     History of Changes
Other Study ID Numbers: Baker - 001
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012

Keywords provided by Johnny Stephens, Oklahoma State University Center for Health Sciences:
HIV
AIDS
HIV/AIDS
Treatment Naive

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
Tenofovir
 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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors