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

NCT00740064 | Unknown Phase 4 DMC

• 1 other identifier: COL111429
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

HIV Infections

Keywords

HIV infections

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy and safety of RTG and ABC/3TC over 48 weeks in ART-naive HIV-infected subjects.

  48 weeks

Secondary Outcomes (1)

• To assess the immunologic response, changes in fasting lipids, renal function, and development of resistance of the study regimen

  48 weeks

Interventions

Raltegravir and Abacavir/Lamivudine DRUG

Raltegravir 400mg BID Abacavir/Lamivudine 1 tablet QD

Also known as: Isentress, Epzicom, RTG, ABC/3TC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):

You may not qualify if:

• 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.

Sponsors & Collaborators

• Denver Infectious Disease Consultants, PLLC: lead
• GlaxoSmithKline: collaborator

Study Sites (3)

Spectrum Medical Group

Phoenix, Arizona, 85012, United States

Location

Denver Infectious Disease Consultants, PLLC

Denver, Colorado, 80220, United States

Location

Southwest CARE Center

Santa Fe, New Mexico, 87505-4765, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium; abacavir; Lamivudine; abacavir, lamivudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Benjamin Young, MD, PhD

  Denver Infectious Disease Consultants, PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 22, 2008
• Study Start: May 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 28, 2009

Record last verified: 2009-01

Locations

US (3)