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

• Status: Unknown status
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of Raltegravir and Epzicom over 48 weeks in ART-naive HIV-infected subjects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denver Infectious Disease Consultants, PLLC
• Collaborator: GlaxoSmithKline
• Treatments: Abacavir; Dideoxynucleosides; Lamivudine; Raltegravir Potassium

Criteria

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.