- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00740064
Pilot Study With Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Treatment Naive HIV-Infected Subjects (SHIELD)
January 27, 2009 updated by: Denver Infectious Disease Consultants, PLLC
A Pilot Study of Highly Active Antiretroviral Therapy Using Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Antiretroviral Naive HIV-Infected Subjects
To evaluate the efficacy and safety of Raltegravir and Epzicom over 48 weeks in ART-naive HIV-infected subjects.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85012
- Spectrum Medical Group
-
-
Colorado
-
Denver, Colorado, United States, 80220
- Denver Infectious Disease Consultants, PLLC
-
-
New Mexico
-
Santa Fe, New Mexico, United States, 87505-4765
- Southwest CARE Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the efficacy and safety of RTG and ABC/3TC over 48 weeks in ART-naive HIV-infected subjects.
Time Frame: 48 weeks
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the immunologic response, changes in fasting lipids, renal function, and development of resistance of the study regimen
Time Frame: 48 weeks
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Benjamin Young, MD, PhD, Denver Infectious Disease Consultants, PLLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Anticipated)
August 1, 2009
Study Completion (Anticipated)
November 1, 2009
Study Registration Dates
First Submitted
August 20, 2008
First Submitted That Met QC Criteria
August 21, 2008
First Posted (Estimate)
August 22, 2008
Study Record Updates
Last Update Posted (Estimate)
January 28, 2009
Last Update Submitted That Met QC Criteria
January 27, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- HIV Integrase Inhibitors
- Integrase Inhibitors
- Raltegravir Potassium
- Lamivudine
- Abacavir
Other Study ID Numbers
- COL111429
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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