Zidovudine and Lamivudine Given Once Versus Twice Daily

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are 12 through 24 years of age.

• Are HIV-positive.

• Weigh more than 40 kg.

• Have a CD4 cell count above 250 cells/microL.

• Have taken at least 4 weeks of 3 or more anti-HIV medications, which must include ZDV and 3TC (as individual drugs or Combivir) and either a protease inhibitor or nonnucleoside reverse transcriptase inhibitor, and do not plan to change these medications during the study period.

• Have consent of a parent or guardian if under 18 years of age.

• Have a negative pregnancy test, if female and able to have children.

• Agree to use 2 effective methods of birth control (birth control pills plus a barrier method or 2 barrier methods) while taking study medication, if female and able to have children.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have an opportunistic (AIDS-related) infection that requires treatment at study entry.

• Are receiving anti-cancer medications for cancer.

• Are taking certain anti-HIV medications (nucleoside or nucleotide reverse transcriptase inhibitors, other than ZDV and 3TC), or hydroxyurea.

• Are pregnant or breast-feeding.

• Have diseases (other than HIV infection) or other conditions that, in the investigator's opinion, would interfere with the study.