Study Stopped
Safety concerns
Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With HIV Infection and Modestly Detectable Viral Load.
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
1 other identifier
interventional
60
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2002
CompletedFirst Posted
Study publicly available on registry
June 25, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedDecember 30, 2015
December 1, 2015
June 21, 2002
December 29, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
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)
- +3 more criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Body Positive, Inc.
Phoenix, Arizona, 85006, United States
Unknown Facility
Los Angeles, California, United States
Pacific Horizon Medical Group, Inc.
San Francisco, California, 94115, United States
Community Health Care Center One, Inc.
Fort Lauderdale, Florida, 33306, United States
South Shore Hospital
Miami Beach, Florida, 33160, United States
AIDS Research Consortium
Atlanta, Georgia, 30308, United States
Unknown Facility
Chicago, Illinois, United States
St. Lukes Roosevelt Hospital
New York, New York, 10019, United States
Stony Brook University Infectious Disease, Dept. of Medicine
Stony Brook, New York, 11794-8153, United States
Unknown Facility
Houston, Texas, 77098, United States
Unknown Facility
Houston, Texas, United States
Hampton Road Medical Specialists
Hampton, Virginia, 23666, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 21, 2002
First Posted
June 25, 2002
Study Completion
May 1, 2003
Last Updated
December 30, 2015
Record last verified: 2015-12