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Pilot Study With Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Treatment Naive HIV-Infected Subjects (SHIELD)

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. Identifier: NCT00740064
Recruitment Status : Unknown
Verified January 2009 by Denver Infectious Disease Consultants, PLLC.
Recruitment status was:  Active, not recruiting
First Posted : August 22, 2008
Last Update Posted : January 28, 2009
Information provided by:
Denver Infectious Disease Consultants, PLLC

Tracking Information
First Submitted Date  ICMJE August 20, 2008
First Posted Date  ICMJE August 22, 2008
Last Update Posted Date January 28, 2009
Study Start Date  ICMJE May 2008
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2008)
To evaluate the efficacy and safety of RTG and ABC/3TC over 48 weeks in ART-naive HIV-infected subjects. [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00740064 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2008)
To assess the immunologic response, changes in fasting lipids, renal function, and development of resistance of the study regimen [ 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 Pilot Study With Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Treatment Naive HIV-Infected Subjects
Official Title  ICMJE A Pilot Study of Highly Active Antiretroviral Therapy Using Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Antiretroviral Naive HIV-Infected Subjects
Brief Summary To evaluate the efficacy and safety of Raltegravir and Epzicom over 48 weeks in ART-naive HIV-infected subjects.
Detailed Description
  • This is a single-arm, multicenter, open-label, pilot study to evaluate the efficacy, safety, and tolerability of RTG BID and ABC/3TC QD. A total of 30 subjects will be enrolled at 3 U.S. sites.
  • The study includes a 30-day screening period, a treatment period (baseline through week 48), and a follow-up visit, 2 to 4 weeks after the last study visit, as needed to resolve any ongoing AEs or to confirm virologic status.

Virologic failure (VF) is defined as having either virologic non-response or virologic rebound. Virologic failure is confirmed by having 2 consecutive plasma HIV-1 RNA levels taken at least 2 weeks apart according to the following definitions:

  • virologic rebound is defined as HIV-1 RNA level ≥400 copies/mL after initial response of HIV-1 RNA <400 copies/mL or >1 log10 copies/mL increase above nadir;
  • virologic non-response is defined as HIV-1 RNA >400 copies/mL at week 24.
  • Subjects will be discontinued from the study if virologic failure is confirmed. When a subject is suspected to have virologic failure, a confirmatory HIV-1 RNA must be performed at an unscheduled visit between 2 weeks and 4 weeks after the initial assessment, and a plasma sample collected for resistance testing.
  • Subjects who experience symptoms consistent with a clinically suspected ABC HSR must permanently discontinue ABC/3TC, and will be allowed to substitute study-provided fixed-dose combination ZDV/3TC 150/300 mg (COMBIVIR®) BID for ABC/3TC and remain in the study.
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: Raltegravir and Abacavir/Lamivudine
Raltegravir 400mg BID Abacavir/Lamivudine 1 tablet QD
Other Names:
  • Isentress
  • Epzicom
  • RTG
  • ABC/3TC
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 21, 2008)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2009
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Antiretroviral naïve defined as ≤7 days of ART prior to study entry
  • Negative for HLA-B*5701 allele
  • Screening HIV-1 RNA >1,000 copies/mL
  • Screening laboratory values:

    • Hemoglobin > 8.0 g/dL
    • Platelet count >50,000/mm3
    • AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 x ULN
    • Total bilirubin <2.5 x ULN
    • Absolute neutrophil count >500/mm3
    • Calculated creatinine clearance (CrCL) ≥50 mL/min by Cockcroft-Gault:
    • For men, (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dL x 72) = CrCl (mL/min)*
    • For women, multiply the result by 0.85 = CrCl (mL/min)
  • A female subject is eligible to participate in the study if she is of:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal); or,
  • Childbearing potential with a negative pregnancy test at screen and agrees to use one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the product label and the instructions of a physician):
  • Agreement for complete abstinence from intercourse from 2 weeks prior to administration of investigational products, throughout the study, and for 2 weeks after discontinuation of all study medications.
  • Double barrier contraception (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide);
  • Any intrauterine device (IUD) with published data showing that the expected failure rate is less than 1% per year (not all IUDs meet this criterion);
  • Any other method with published data showing that the lowest expected failure rate for the method is less than 1% per year.
  • Men and women age (≥18 years).
  • Ability and willingness of subject to give written informed consent.

Exclusion Criteria:

  • Screening HIV-1 genotype indicating the presence of any of the following mutations: K65R, L74V, and Y115F or a combination of two or more thymidine analog mutations (M41L, D67N, K70R, K219Q or E) that include changes at either L210 or T215, associated with ABC and 3TC resistance, and mutations Q148H/R/K and N155H associated with RTG resistance.
  • Currently pregnant or breast-feeding.
  • Hepatitis B infection with chronic viral replication (HBsAg+).
  • Presence of a serious medical condition, including but not limited to congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the subject.
  • Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. NOTE: Use of corticosteroids for acute therapy for PCP is permitted. Prednisone at a daily dose of 10 mg or less (physiologic replacement dose) or short course corticosteroid therapy (≤ 10 days) is permitted.
  • Known allergy/sensitivity to study drugs or their formulations.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Illnesses that are determined serious by the site investigator, (i.e. requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy, for at least 7 days prior to study entry.
  • Requirement for medications that are not allowed to be taken with study treatment.
  • Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical (e.g. infectious disease) illness.
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 United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00740064
Other Study ID Numbers  ICMJE COL111429
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Benjamin Young, MD, PhD, Denver Infectious Disease Consultants, PLLC
Study Sponsor  ICMJE Denver Infectious Disease Consultants, PLLC
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Benjamin Young, MD, PhD Denver Infectious Disease Consultants, PLLC
PRS Account Denver Infectious Disease Consultants, PLLC
Verification Date January 2009

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