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Home > "Z" Clinical Trials Conditions > Zidovudine and Lamivudine Given Once Versus Twice Daily  Zidovudine and Lamivudine Given Once Versus Twice Daily
Zidovudine and Lamivudine Given Once Versus Twice Daily
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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.
Details: Initial dosing regimens of ZDV were based on the plasma half-life of the drug. However, recent studies of the intracellular metabolism of ZDV have demonstrated that the active anabolite, ZDV-TP, is present within the cell for an extended period of time relative to the drug in the plasma. This suggests that antiviral activity may be present for a sufficient time frame with less-frequent dosing of the drug. Careful comparison of the rate and extent of intracellular phosphorylated ZDV metabolites as a function of schedule will determine whether less-frequent dosing has a sound pharmacological basis. Also, the intracellular metabolism of 3TC is via different enzymes than that of ZDV and there are quantitative differences in the amount of triphosphate formed from both drugs. This study will provide information about intracellular metabolites when both ZDV and 3TC are concurrently administered. 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.)
Eligibility:
Study Type: Interventional, Treatment, Crossover Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 12 Years/24 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
PatriciaFlynn, Study Chair,
St Joseph's Hosp & Med Center
Paterson, New Jersey, 07503
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
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 Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Univ of California, San Diego
San Diego, California, 92103
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Additional Information:
Study ID Numbers: ACTG P1012; PACTG P1012
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014014
Other Hiv Infections Studies:
1. A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood
2. A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients
3. A Study to Compare the Safety and Effectiveness of Indinavir Combined with Stavudine and Lamivudine
4. A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients with AIDS
5. Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients with Both HBV and HIV
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Zidovudine and Lamivudine Given Once Versus Twice Daily
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