Zidovudine and Lamivudine Given Once Versus Twice Daily
Status:
Completed
Trial end date:
2002-08-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to see if the full daily dose of Combivir (zidovudine
[ZDV]/lamivudine [3TC]) taken once a day is as effective as the usual recommended twice-a-day
dose.
Studies have shown that the antiviral activity of ZDV can continue in the body even after
there does not appear to be any ZDV left in the blood. This occurs because the body breaks
down the drug into substances that remain active against HIV. The body also breaks down 3TC,
a drug that is combined with ZDV in the Combivir product, in a similar way. Since antiviral
activity may continue after Combivir is removed from the body, it may not be necessary to
take the drug as often as once thought. This study carefully measures levels of the active
substances in order to find out whether the same amount of antiviral activity occurs with
less-frequent dosing.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Treatments:
Lamivudine Lamivudine, zidovudine drug combination Zidovudine