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 |
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.
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
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