search
Back to results

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

Primary Purpose

HIV Infections

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ACH126-443 (Beta-L-Fd4C)
Sponsored by
Alexion
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring treatment experienced,, Stable triple anti-retroviral combination therapy in HIV-infected,, Achillion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Body Positive, Inc.
  • Pacific Horizon Medical Group, Inc.
  • Community Health Care Center One, Inc.
  • South Shore Hospital
  • AIDS Research Consortium
  • St. Lukes Roosevelt Hospital
  • Stony Brook University Infectious Disease, Dept. of Medicine
  • Hampton Road Medical Specialists
  • Swedish Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 21, 2002
Last Updated
December 29, 2015
Sponsor
Alexion
search

1. Study Identification

Unique Protocol Identification Number
NCT00040157
Brief Title
Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Safety concerns
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alexion

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
treatment experienced,, Stable triple anti-retroviral combination therapy in HIV-infected,, Achillion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ACH126-443 (Beta-L-Fd4C)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Body Positive, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
L.a.
State/Province
California
Country
United States
Facility Name
Pacific Horizon Medical Group, Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Community Health Care Center One, Inc.
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
South Shore Hospital
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33160
Country
United States
Facility Name
AIDS Research Consortium
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
St. Lukes Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Stony Brook University Infectious Disease, Dept. of Medicine
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8153
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
City
Houston
State/Province
Texas
Country
United States
Facility Name
Hampton Road Medical Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.achillion.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs