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

Stopped early · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00040157

Run by

Alexion Pharmaceuticals, Inc.

People needed

60

Expected to finish

2003-05-01

Last updated by the study team

2015-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Body Positive, Inc. — Phoenix, Arizona, United States
• Study site — Los Angeles, California, United States
• Pacific Horizon Medical Group, Inc. — San Francisco, California, United States
• Community Health Care Center One, Inc. — Fort Lauderdale, Florida, United States
• South Shore Hospital — Miami Beach, Florida, United States
• AIDS Research Consortium — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• St. Lukes Roosevelt Hospital — New York, New York, United States
• Stony Brook University Infectious Disease, Dept. of Medicine — Stony Brook, New York, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Hampton Road Medical Specialists — Hampton, Virginia, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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