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



Status:Terminated
Conditions:HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
End Date:May 2003

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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

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.


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
We found this trial at
12
sites
San Francisco, California 94115
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Atlanta, Georgia 30308
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Chicago, IL
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Ft. Lauderdale, Florida 33306
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Hampton, Virginia 23666
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Hampton, VA
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Houston, TX
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L.a., CA
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Miami Beach, Florida 33160
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Miami Beach, FL
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New York, New York 10025
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New York, NY
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Phoenix, Arizona 85006
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Phoenix, AZ
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Seattle, WA
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Stony Brook, NY
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