BLADE: Comparison of Once Daily Lopinavir/Ritonavir to Lopinavir/Ritonavir BID Dosing in HIV-Infected Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Bellos, Nicholaos C., M.D..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Bellos, Nicholaos C., M.D.
ClinicalTrials.gov Identifier:
NCT00388492
First received: October 12, 2006
Last updated: January 10, 2007
Last verified: October 2006
  Purpose

The goal of this study is to evaluate the proportion of subjects both antiretroviral experienced and virologically suppressed on lopinavir/ritonavir (LPV/r)400/100mg twice daily who maintain viral suppression after switching to lopinavir/ritonavir (LPV/r)800/200mg once daily.

The hypothesis for this study is that the majority of subjects will remain virologically suppressed with once daily dosing versus twice daily dosing and therefore quality of life will be improved with the once daily dosing of lopinavir/ritonavir (LPV/r)800/200mg.


Condition Phase
HIV Infections
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: BLADE: "A Comparison of Once Daily LPV/r to LPV/r BID in HIV-Infected Virologically Controlled Antiretroviral Experienced Subjects"

Resource links provided by NLM:


Further study details as provided by Bellos, Nicholaos C., M.D.:

Estimated Enrollment: 45
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Documentation HIV infection
  • Male or Female
  • 18 years of age
  • Previously failed an NNRTI and/or 1 previous PI containing regimen
  • Currently virologically controlled (VL<50 copies/mL) on a LPV/r containing regimen ≥ 3 months
  • Any CD4+ cell count
  • Cognitive ability to understand and provide written informed consent and willingness to participate in and comply with the study protocol
  • Patient does not currently have or has not been treated for an active opportunistic infection (OI) consistent with CDC definition (Appendix B) within 30 days of screening
  • Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness
  • A female is eligible to enter and participate in this study if she is of:

    • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal) or
    • 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 of 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 below:
      • Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
      • Any intrauterine device(IUD) with published data showing that the expected failure rate is <1% per year (not all IUD's meet this criterion)
      • Sterilization (female patient or male partner of female patient)
      • Any other methods with published data showing that the lowest expected failure rate for that method is <1% per year 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:

  • Pregnancy or breastfeeding
  • Hemodialysis or peritoneal dialysis
  • Patients unable to provide written informed consent
  • Use of concurrent medications known to affect lopinavir and/or ritonavir concentrations (as listed in the attached Kaletra package insert)
  • Patient with active AIDS-defining opportunistic infection or disease according to the 1993 CDC AIDS surveillance definition (Clinical Category C) that, in the opinion of the investigator, would prelude the patient from participating in the study (See Appendix B)
  • History of active substance abuse, excluding cannabis, or psychiatric illness that, in the opinion of the investigator, would preclude compliance with the protocol, dosing schedule and assessments.
  • Patient is either pregnant at the 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
  • Patient suffers from a 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
  • Patient has malabsorption syndrome or other gastrointestinal dysfunction, which may interfere with drug absorption or render the patient unable to take oral medication
  • HBV coinfection
  • Patient has any of the following laboratory results within 30 days prior to the first dose of study medication:

    • Hemoglobin concentration <8.0g/dl
    • Absolute neutrophil count <750cells/mm3
    • Platelet count <50,000cells/mm3
    • Aminotransferase (AST, ALT) >3 times ULN
    • Serum creatinine >1.5 times the Upper Limits of Normal (ULN)
  • Patient has required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to entry, or has an anticipated need for these agents within the study period
  • Patient requires treatment with 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.
  • Patient receiving methadone therapy
  • Patients requiring foscarnet therapy or therapy with other agents with documented activity against HIV-1 invitro
  • Patient prescribed/taking astemizole, terfenadine, cisapride, midazolam, triazolam, flecainide, pimozide, propafenone, St. John's Wort, lovastatin, simvastatin, and rifampin or ergot derivatives (see section 5.5 Concomitant Medications and Non-Drug Therapies and Appendix C
  • Patient has a history of allergy to any of the study drugs or any excipients therein.
  • In addition, patients non-compliant with study medication during 2-4 week study periods despite adherence counseling will not be retained in the study due to increased risk for selective pressure and potential development of protease resistance.
  • 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: NCT00388492

Contacts
Contact: Keri Neuling 214-828-4702 ext 122 kneuling@drbellos.com
Contact: Denise Ramos 214-828-4702 ext 102 dramos@drbellos.com

Locations
United States, Texas
Nicholaos C. Bellos, MD Not yet recruiting
Dallas, Texas, United States, 75204
Contact: Keri Neuling    214-828-4702 ext 122    kneuling@drbelllos.com   
Contact: Denise Ramos    214-828-4702 ext 102    dramos@drbellos.com   
Principal Investigator: Nicholaos C. Bellos, MD         
Sponsors and Collaborators
Bellos, Nicholaos C., M.D.
Investigators
Principal Investigator: Nicholaos C. Bellos, MD Nicholaos C. Bellos, MD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00388492     History of Changes
Other Study ID Numbers: 70-1002-075
Study First Received: October 12, 2006
Last Updated: January 10, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Bellos, Nicholaos C., M.D.:
HIV Infected

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Lopinavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014