Zidovudine and Lamivudine Given Once Versus Twice Daily

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00014014

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

20

Expected to finish

2002-08-01

Last updated by the study team

2013-10-07

Who can join

Age: 12 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Univ of California, San Diego — San Diego, California, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Emory Univ Hosp / Pediatrics — Atlanta, Georgia, United States
• Mt Sinai Hosp Med Ctr / Dept of Pediatrics — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Tulane Univ / Charity Hosp of New Orleans — New Orleans, Louisiana, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Univ of Mississippi Med Ctr — Jackson, Mississippi, United States
• Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States
• St Joseph's Hosp & Med Center — Paterson, New Jersey, United States
• Metropolitan Hosp Ctr — New York, New York, United States
• State Univ of New York at Stony Brook — Stony Brook, New York, United States
• SUNY Health Sciences Ctr at Syracuse / Pediatrics — Syracuse, New York, United States
• Children's Hosp of Philadelphia — Philadelphia, Pennsylvania, United States
• Temple University School of Medicine — Philadelphia, Pennsylvania, United States
• Saint Jude Children's Research Hosp of Memphis — Memphis, Tennessee, United States
• Texas Children's Hosp / Baylor Univ — Houston, Texas, United States
• Univ of Puerto Rico / Univ Children's Hosp AIDS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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