Pilot Study With Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Treatment Naive HIV-Infected Subjects (SHIELD)
Verified January 2009
Denver Infectious Disease Consultants, PLLC
Information provided by (Responsible Party)
Denver Infectious Disease Consultants, PLLC
First received: August 20, 2008
Last updated: January 27, 2009
Last Verified: January 2009
History of Changes
To evaluate the efficacy and safety of Raltegravir and Epzicom over 48 weeks in ART-naive HIV-infected subjects.
Drug : Raltegravir and Abacavir/Lamivudine
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Highly Active Antiretroviral Therapy Using Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Antiretroviral Naive HIV-Infected Subjects|
Further study details as provided by Denver Infectious Disease Consultants, PLLC:
Primary Outcome Measures
- To evaluate the efficacy and safety of RTG and ABC/3TC over 48 weeks in ART-naive HIV-infected subjects. [ Time Frame: 48 weeks ]
- To assess the immunologic response, changes in fasting lipids, renal function, and development of resistance of the study regimen [ Time Frame: 48 weeks ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||November 2009|
|Estimated Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
- 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:
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
Contacts and LocationsChoosing 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: NCT00740064
Locations Show More
|United States, Arizona|
|Spectrum Medical Group|
|Phoenix, Arizona, United States, 85012|
|United States, Colorado|
|Denver Infectious Disease Consultants, PLLC|
|Denver, Colorado, United States, 80220|
|United States, New Mexico|
|Southwest CARE Center|
|Santa Fe, New Mexico, United States, 87505-4765|
Sponsors and CollaboratorsDenver Infectious Disease Consultants, PLLC
|Principal Investigator:||Benjamin Young, MD, PhD||Denver Infectious Disease Consultants, PLLC|
|Responsible Party:||Benjamin Young, MD, PhD, Denver Infectious Disease Consultants, PLLC|
|ClinicalTrials.gov Identifier:||NCT00740064 History of Changes|
|Other Study ID Numbers:||COL111429|
|Study First Received:||August 20, 2008|
|Last Updated:||January 27, 2009|
Keywords provided by Denver Infectious Disease Consultants, PLLC:HIV infections
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on May 28, 2020
This information is provided by ClinicalTrials.gov.