Zidovudine and Lamivudine Given Once Versus Twice Daily
NCT ID: NCT00014014
Last Updated: 2013-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2002-08-31
Brief Summary
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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.
Detailed Description
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This is a study of 2 schedules of Combivir therapy. At study entry or Part I, all patients take Combivir twice daily for the 7-day adherence assessment. Patients who have demonstrated 70 percent or greater adherence \[AS PER AMENDMENT 7/20/01: 70 percent compliance with the study regimen for Combivir. This corresponds to taking at least 10 of the prescribed 14 Combivir tablets during the 7 days prior to an adherence assessment, including all scheduled doses in the 24-hour period prior to that assessment.\], and have taken all scheduled Combivir doses in the previous 24 hours, have pharmacokinetic samples obtained and are randomized to Group A or Group B in Part II. Group A patients take 2 Combivir tablets once daily; Group B patients take 1 Combivir tablet twice daily. After patients have completed the targeted duration of Part II (7 days for Group A and 7-14 days for Group B), they are assessed for adherence. Patients who have demonstrated 70 percent or greater adherence, and have taken all scheduled Combivir doses in the previous 24 hours, have pharmacokinetic samples obtained and then change to the alternate dosing schedule. Group A patients take 1 Combivir tablet twice daily; Group B patients take 2 Combivir tablets once daily. After patients have completed the targeted duration of Part III (7-14 days for Group A and 7 days for Group B), they are assessed for adherence. All patients who meet the adherence criteria have pharmacokinetic samples obtained. After completion of Part III pharmacokinetic studies, patients have completed the study. (Note: Combivir will not be provided in this study.)
Conditions
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Keywords
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Study Design
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CROSSOVER
TREATMENT
Interventions
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Lamivudine/Zidovudine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
24 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Patricia Flynn
Role: STUDY_CHAIR
Locations
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Metropolitan Hosp Ctr
New York, New York, United States
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
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
Countries
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References
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Flynn PM, Rodman J, Lindsey JC, Robbins B, Capparelli E, Knapp KM, Rodriguez JF, McNamara J, Serchuck L, Heckman B, Martinez J; PACTG P1012 Team. Intracellular pharmacokinetics of once versus twice daily zidovudine and lamivudine in adolescents. Antimicrob Agents Chemother. 2007 Oct;51(10):3516-22. doi: 10.1128/AAC.01626-06. Epub 2007 Jul 30.
Other Identifiers
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PACTG P1012
Identifier Type: -
Identifier Source: secondary_id
ACTG P1012
Identifier Type: -
Identifier Source: secondary_id
11648
Identifier Type: REGISTRY
Identifier Source: secondary_id
P1012
Identifier Type: -
Identifier Source: org_study_id