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A Study Exploring an Induction-Maintenance Kaletra-Based Therapy Versus a Sustiva-Based Regimen in Previously Non-Treated, HIV-1/HCV Co-Infected Subjects

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: NCT00121017
Recruitment Status : Withdrawn
First Posted : July 21, 2005
Last Update Posted : July 27, 2006
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE July 14, 2005
First Posted Date  ICMJE July 21, 2005
Last Update Posted Date July 27, 2006
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2006)
The proportion of subjects with a plasma HIV-1 RNA level below 50 copies/mL at Week 96.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2006)
  • Vital signs
  • Physical examinations
  • Clinical laboratory tests
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Exploring an Induction-Maintenance Kaletra-Based Therapy Versus a Sustiva-Based Regimen in Previously Non-Treated, HIV-1/HCV Co-Infected Subjects
Official Title  ICMJE A Randomized, Open-Label Study Assessing Safety, Tolerability and Efficacy of an Induction-Maintenance Treatment Strategy Including Lopinavir/Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine Versus Efavirenz Plus Tenofovir Disoproxil Fumarate and Emtricitabine in Antiviral-naïve HIV-1/HCV Co-Infected Subjects
Brief Summary The purpose of this study is to determine whether a simplified lopinavir/ritonavir-based therapy will continue to keep the viral load at very low levels after initial treatment with a combination of Kaletra (lopinavir/ritonavir) plus tenofovir and emtricitabine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infection
  • Hepatitis C
Intervention  ICMJE
  • Drug: Kaletra (lopinavir/ritonavir)
  • Drug: Sustiva (efavirenz)
  • Drug: Truvada (emtricitabine/tenofovir disoproxil fumarate)
Study Arms  ICMJE Not Provided
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 Withdrawn
Enrollment  ICMJE
 (submitted: July 26, 2006)
200
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is at least 18 years of age.
  • Subject's plasma HIV-1 RNA is >1000 copies/mL at screening and in the investigator's opinion, the subject requires antiretroviral therapy.
  • Subject is naive to antiretroviral therapy or has received <7 days total of any antiretroviral therapy >30 days prior to study drug administration.
  • Subject has chronic HCV based on detectable plasma HCV RNA level (>600 IU/mL) at screening.
  • Subject is not currently undergoing treatment of HCV infection and does not plan to initiate HCV treatment for the duration of this study.
  • If female, the results of a urine pregnancy test performed at screening and on Day-1/Baseline are both negative.
  • If female, subject is either not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device, a vasectomized partner or total abstinence from sexual intercourse.
  • Subject is not breastfeeding.
  • Subject's vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
  • Subject agrees not to take any drugs during the study, including over-the-counter medicines, vitamins, mineral supplements, herbal preparations, alcohol or recreational drugs without the knowledge and permission of the investigator.
  • Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of initiating study drug.
  • Subject has voluntarily signed and dated an informed consent from, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.

Exclusion Criteria:

  • Subject has a history of an allergic reaction or significant sensitivity to lopinavir, ritonavir, tenofovir, emtricitabine, lamivudine, and efavirenz or to any inert materials contained in the study drug formulations.
  • Subject has a significant history of cardiac, renal, neurologic, psychiatric, oncologic or metabolic disease that would, in the opinion of the investigator, adversely affect his/her participation in this study.
  • Subject has chronic hepatic disease of any etiology other than HCV infection (including hemochromatosis, autoimmune hepatitis, Wilson's Disease, and hepatocellular carcinoma).
  • Subject has a liver biopsy result consistent with advanced chronic cirrhosis or a Child Pugh Score of "C".
  • Subject is currently taking or will require any drugs that are contraindicated or have significant pharmacokinetic interactions with study drugs during the course of the study. For complete information refer to the most current product label for locally approved prescribing information for lopinavir/ritonavir (Kaletra), efavirenz (Sustiva), tenofovir disoproxil fumarate (Viread), emtricitabine (Emtriva), co-formulated emtricitabine/tenofovir disoproxil fumarate (Truvada) and lamivudine (Epivir).
  • Subject has ongoing history of drug and/or alcohol abuse or psychiatric illness that in the investigator's opinion could preclude compliance with the protocol.
  • Subject has received any investigational drug or vaccine within 30 days prior to study drug administration.
  • The screening HIV-1 genotype resistance report suggests resistance or possible resistance to the study RTI(s) or lopinavir/ritonavir; Evidence of possible resistance to efavirenz; Presence of one of the following mutations: RT L1001, K103N, V106A or M, V108I, Y181C or I, Y188L, G190A or S, P225H, M230L; Evidence of possible resistance to emtricitabine or lamivudine; Presence of one of the following mutations: RTm184V or I; Evidence of possible resistance to tenofovir; Presence of RT K65R or insertion at codon 69, or Presence of 2 or more of the following mutations: RTm41L, D67N, K70R, L210W; any change at T215, K219Q or evidence of possible resistance to lopinavir/ritonavir; Presence of one or more of the following mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, 190M or Presence of 3 or more of the following mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L; any change at I54, A71V or T, G73S.
  • Screening laboratory analyses show any of the following abnormal laboratory results: Presence of hepatitis B surface antigen (HBsAg) or anti-HBcAB (Total Ig, Total Bilirubin >/= 2.5x upper limit of normal (ULN), Hemoglobin <8.0 g/dL, Absolute neutrophil count < 750 cells/uL, Platelet count < 50,000/mL, ALT (SGPT) or AST (SGOT) > 5.0x ULN, Creatinine > 1.5x ULN, Calculated creatinine clearance < 50 mL/min, PT > 3.0 seconds prolonged from the ULN.
  • For any reason, subject is considered by the investigator to be an unsuitable candidate to participate in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00121017
Other Study ID Numbers  ICMJE M05-731
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Medical Information Abbott
PRS Account Abbott
Verification Date July 2006

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