Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation
Completed · Phase 1/Phase 2
Conditions studied: HIV Infections
In brief
Human immunodeficiency virus (HIV)-1 infected participants receiving long-term therapy with lamivudine or emtricitabine (nucleoside reverse transcriptase inhibitors \[NRTIs\]) are at risk for the development of a mutation at position M184 on the HIV reverse transcriptase gene. This mutation confers resistance to both drugs (\>100 fold increase in the concentration of drug producing 50% inhibition \[IC50\]). In-vitro studies with elvucitabine have shown that HIV-1 isolates with the M184V mutation show only a 10-fold increase in IC50 as compared to wild type HIV-1. Alexion Pharmaceuticals Inc. intention is to demonstrate that 10 milligrams (mg) of elvucitabine, administered once per day for 14 days with continued background anti-HIV-1 medications, will demonstrate a fall in HIV-1 ribonucleic acid (RNA) plasma levels, as compared to baseline. The data from this study will guide dosing in future long-term studies in HIV-1 infected participants with the M184V mutation.
Key facts
- Study ID
- NCT00312039
- Run by
- Alexion Pharmaceuticals, Inc.
- People needed
- 20
- Starts
- 2006-03-31
- Expected to finish
- 2007-10-31
- Last updated by the study team
- 2023-08-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinically stable HIV-1 infected participants
- Ages >18 and <65 years
- Documented M184V mutation
- CD4 cell count >100 cells/mL
- Plasma HIV-1 RNA levels >5000 and <150,000 copies/milliliter (mL)
- Currently receiving lamivudine or emtricitabine
- Other hematologic and metabolic parameters must be met.
- Provide written informed consent
- Other inclusion criteria apply.
You may not qualify if…
- Hepatitis B antigen positive
- HIV-1 genotype positive for more than or equal to 4 protease mutations
- HIV-1 genotype positive for more than or equal to 2 non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations
- Previous therapy with cytotoxic or myelosuppressive drugs in the past 3 months
- Evidence or history of cirrhosis
- Women who are pregnant or breast feeding
- Other exclusion criteria apply.
Where it is running
- Clinical Trial Site — Birmingham, Alabama, United States
- Clinical Trial Site — Sacramento, California, United States
- Clinical Trial Site — Miami, Florida, United States
- Clinical Trial Site — Orlando, Florida, United States
- Clinical Trial Site — West Palm Beach, Florida, United States
- Clinical Trial Site — Atlanta, Georgia, United States
- Clinical Trial Site — New York, New York, United States
- Clinical Trial Site — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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