Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.

A Phase 2 Trial of 4 Weeks of ACH-126,443 in Comparison With Continued Lamivudine in Stable Triple Antiretroviral Combination Therapy in HIV-Infected Subjects With Modestly Detectable Viral Load

To determine safety and efficacy of ACH-126,443 on the treatment of adults with HIV infection who have modestly detectable viral load while on stable triple combination antiretroviral therapy including 3TC.

Study Overview

• Status: Terminated
• Conditions: HIV Infections
• Intervention / Treatment: Drug: ACH126-443 (Beta-L-Fd4C)

• Study Type: Interventional
• Enrollment: 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Body Positive, Inc.
  • California
    • L.a., California, United States
    • San Francisco, California, United States, 94115
      • Pacific Horizon Medical Group, Inc.
  • Florida
    • Ft. Lauderdale, Florida, United States, 33306
      • Community Health Care Center One, Inc.
    • Miami Beach, Florida, United States, 33160
      • South Shore Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • AIDS Research Consortium
  • Illinois
    • Chicago, Illinois, United States
  • New York
    • New York, New York, United States, 10019
      • St. Lukes Roosevelt Hospital
    • Stony Brook, New York, United States, 11794-8153
      • Stony Brook University Infectious Disease, Dept. of Medicine
  • Texas
    • Houston, Texas, United States
    • Houston, Texas, United States, 77098
  • Virginia
    • Hampton, Virginia, United States, 23666
      • Hampton Road Medical Specialists
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

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:

• Adults ≥18 years of age
• Receiving a stable triple combination antiretroviral regimen including 3TC, one other NRTI and either an NNRTI or a protease inhibitor for at least 4 months (16 weeks)
• Demonstration of initial viral suppression and subsequent rebound to be defined as an initial virological drop of at least 0.5 Logs on a 3TC-containing regimen
• Plasma HIV RNA level > 1000 and < 30,000 copies/mL on two occasions
• Genotypically documented M184V variant of HIV RT
• Clinically stable HIV status with no AIDS-defining events
• CD4 > 200 cells/mm3
• Basic hematologic and chemistry parameters within acceptable limits (defined in protocol)
• All women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L of b-HCG) within 72 hours prior to the start of study medication
• No active opportunistic infection requiring treatment
• Subject must be able to provide written informed consent
• Baseline laboratory values measured within 28 days of initiating study drug as follows:
• HGB≥9.0g/dl or HCT≥27% (in the absence of blood transfusions or erythropoietin treatment in the preceding two weeks
• Absolute neutrophil count≥1000 cells/mm(^3) (in the absence of on-going G-CSF therapy
• Platelet count ≥75,000/mm(^3)
• AST <7.0 times the upper limit of normal
• ALT ,7.0 times the upper limit of normal
• Serum creatinine <1.1 times the upper limit of normal

Exclusion Criteria

• Evidence of active HBV infection as demonstrated by HBsAg positivity
• Hepatitis C co-infection
• Concurrent systemic antiviral treatment
• Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start.
• Alcohol abuse
• Pregnancy or breast-feeding
• Inability to tolerate oral medication
• AST > 7.0 times the upper limit of normal
• ALT > 7.0 times the upper limit of normal
• Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
• Use of any other drug or substance with anti-HBV activity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Alexion

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Completion (Actual): May 1, 2003

Study Registration Dates

• First Submitted: June 21, 2002
• First Submitted That Met QC Criteria: June 24, 2002
• First Posted (Estimate): June 25, 2002

Study Record Updates

• Last Update Posted (Estimate): December 30, 2015
• Last Update Submitted That Met QC Criteria: December 29, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Achillion; treatment experienced,; Stable triple anti-retroviral combination therapy in HIV-infected,
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Infections; Acquired Immunodeficiency Syndrome; 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; Dexelvucitabine
• Other Study ID Numbers: ACH443-006