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

This study has been terminated.
(Safety concerns)
Sponsor:
Information provided by:
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00040157
First received: June 21, 2002
Last updated: August 18, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: ACH126-443 (Beta-L-Fd4C)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Achillion Pharmaceuticals:

Estimated Enrollment: 60
Study Completion Date: May 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing 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: NCT00040157

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00040157     History of Changes
Other Study ID Numbers: ACH443-006
Study First Received: June 21, 2002
Last Updated: August 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Achillion Pharmaceuticals:
treatment experienced,
Stable triple anti-retroviral combination therapy in HIV-infected,
Achillion

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Communicable Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 29, 2014