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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00040157
• Other study ID #: ACH443-006
• Status: Terminated
• Phase: Phase 2
• First received: June 21, 2002
• Last updated: December 29, 2015
• Est. completion date: May 2003

Study information

• Verified date: December 2015
• Source: Achillion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

Drug:
• ACH126-443 (Beta-L-Fd4C)

Locations

Country	Name	City	State
United States	AIDS Research Consortium	Atlanta	Georgia
United States	Community Health Care Center One, Inc.	Ft. Lauderdale	Florida
United States	Hampton Road Medical Specialists	Hampton	Virginia
United States	South Shore Hospital	Miami Beach	Florida
United States	St. Lukes Roosevelt Hospital	New York	New York
United States	Body Positive, Inc.	Phoenix	Arizona
United States	Pacific Horizon Medical Group, Inc.	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	Stony Brook University Infectious Disease, Dept. of Medicine	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Achillion Pharmaceuticals

Country where clinical trial is conducted

United States, 

External Links

•   Link