Status:
UNKNOWN
Pilot Study With Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Treatment Naive HIV-Infected Subjects
Lead Sponsor:
Denver Infectious Disease Consultants, PLLC
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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. * Th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00740064
Start Date
May 1 2008
End Date
November 1 2009
Last Update
January 28 2009
Active Locations (3)
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1
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
2
Denver Infectious Disease Consultants, PLLC
Denver, Colorado, United States, 80220
3
Southwest CARE Center
Santa Fe, New Mexico, United States, 87505-4765