Zidovudine and Lamivudine Given Once Versus Twice Daily
A Phase I Pharmacokinetic Study of Once Versus Twice Daily Dosing With Zidovudine and Lamivudine
4 other identifiers
interventional
20
2 countries
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv-infections
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2002
CompletedOctober 7, 2013
October 1, 2013
April 7, 2001
October 4, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Univ of California, San Diego
San Diego, California, 92103, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714, United States
St Joseph's Hosp & Med Center
Paterson, New Jersey, 07503, United States
Metropolitan Hosp Ctr
New York, New York, 10029, United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318, United States
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067, Puerto Rico
Related Publications (1)
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.
PMID: 17664328RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Patricia Flynn
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2001
First Posted
August 31, 2001
Study Completion
August 1, 2002
Last Updated
October 7, 2013
Record last verified: 2013-10