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

Phase 2

Terminated

• Conditions: HIV Infections

• Registration Number: NCT00040157
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-06-21
• Study First Submitted QC: 2002-06-24
• Study First Posted: 2002-06-25
• Study Completion: 2003-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-29
• Last Update Posted: 2015-12-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (9)

Stony Brook University Infectious Disease, Dept. of Medicine; 🇺🇸 Stony Brook, New York, United States

Community Health Care Center One, Inc.; 🇺🇸 Ft. Lauderdale, 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

Hampton Road Medical Specialists; 🇺🇸 Hampton, Virginia, United States

South Shore Hospital; 🇺🇸 Miami Beach, Florida, United States

AIDS Research Consortium; 🇺🇸 Atlanta, Georgia, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States