Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.
Study Identifier:
ACH443-006
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other
Study Details
Medical Condition
- Human Immunodeficiency Virus
Study Drug
- Drug: ACH126-443 (Beta-L-Fd4C)
Date
N/A - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
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
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Human Immunodeficiency Virus
Study Drug
- Drug: ACH126-443 (Beta-L-Fd4C)
Date
N/A - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
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
Protocol 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.
Trial Locations
Location
Status
Location
Body Positive, Inc.
Phoenix, Arizona, United States, 85006
Status
N/A
Location
Los Angeles, California, United States
Status
N/A
Location
Pacific Horizon Medical Group, Inc.
San Francisco, California, United States, 94115
Status
N/A
Location
Community Health Care Center One, Inc.
Fort Lauderdale, Florida, United States, 33306
Status
N/A
Location
South Shore Hospital
Miami Beach, Florida, United States, 33160
Status
N/A
Location
AIDS Research Consortium
Atlanta, Georgia, United States, 30308
Status
N/A
Go to page