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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Hoffmann-La Roche |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000718 |
To determine if alternating zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) (first one and then the other) or intermittent therapy (1 week of drug then 1 week off) will lessen the toxic effects of either drug alone, while still inhibiting HIV (the AIDS virus) in patients with AIDS or AIDS related complex.
AZT extends the survival of some patients with AIDS, and both AZT and ddC are known to inhibit the growth of HIV. When AZT or ddC is given continuously over a prolonged period of time, toxic effects occur that are not found when the drugs are given for 4 - 6 weeks. It is hoped that by alternating the drugs or by giving one drug intermittently, the toxic effects can be decreased without lowering the therapeutic effectiveness of the drugs.
Condition | Intervention |
HIV Infections |
Drug: Zidovudine Drug: Zalcitabine |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Zidovudine Zalcitabine Thymidine |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC |
Estimated Enrollment: | 112 |
AZT extends the survival of some patients with AIDS, and both AZT and ddC are known to inhibit the growth of HIV. When AZT or ddC is given continuously over a prolonged period of time, toxic effects occur that are not found when the drugs are given for 4 - 6 weeks. It is hoped that by alternating the drugs or by giving one drug intermittently, the toxic effects can be decreased without lowering the therapeutic effectiveness of the drugs.
Patients will be assigned to 1 of 7 treatment groups. Both AZT and ddC will be given by mouth every 4 hours. One group will take AZT continuously for 52 weeks. One group will alternate 1 week of AZT with a week with no drug for 48 weeks and another group will alternate 1 week of ddC with a week of no drug for 48 weeks. Other groups will alternate AZT and either low-dose or high-dose ddC on a weekly basis or a monthly basis for 48 weeks. Patients will be seen weekly for the first 8 weeks of study and less often thereafter. Blood samples will be withdrawn frequently and evaluated for possible changes in the immune system, toxic effects, and possible changes in the amount of HIV in the blood. Lumbar punctures and skin biopsies will also be performed.
AMENDED: All patients receiving continuous AZT will be switched to a lower dose of AZT if they have not already been switched. This is in accordance with results of NIAID ACTG 002, 016, and 019 which demonstrate that this dose of AZT delays progression of HIV symptoms.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Encouraged though not required:
Concurrent Treatment:
Allowed:
All patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Any negative HIV p24 antigen test during the month prior to entry will exclude the patient from the study.
Active drug or alcohol abuse.
United States, California | |||||
Univ of California / San Diego Treatment Ctr | |||||
San Diego, California, United States, 921036325 | |||||
Stanford Univ School of Medicine | |||||
Stanford, California, United States, 94305 | |||||
Los Angeles County - USC Med Ctr | |||||
Los Angeles, California, United States, 90033 | |||||
United States, District of Columbia | |||||
George Washington Univ Med Ctr | |||||
Washington, District of Columbia, United States, 20037 | |||||
United States, Florida | |||||
Univ of Miami School of Medicine | |||||
Miami, Florida, United States, 331361013 | |||||
United States, Illinois | |||||
Rush Presbyterian - Saint Luke's Med Ctr | |||||
Chicago, Illinois, United States, 60612 | |||||
Northwestern Univ Med School | |||||
Chicago, Illinois, United States, 60611 | |||||
United States, Louisiana | |||||
Charity Hosp / Tulane Univ Med School | |||||
New Orleans, Louisiana, United States, 70112 | |||||
Louisiana State Univ Med Ctr / Tulane Med School | |||||
New Orleans, Louisiana, United States, 70112 | |||||
Tulane Univ School of Medicine | |||||
New Orleans, Louisiana, United States, 70112 | |||||
United States, Massachusetts | |||||
Harvard (Massachusetts Gen Hosp) | |||||
Boston, Massachusetts, United States, 02114 | |||||
United States, Minnesota | |||||
Univ of Minnesota | |||||
Minneapolis, Minnesota, United States, 55455 | |||||
United States, New York | |||||
Saint Luke's - Roosevelt Hosp Ctr | |||||
New York, New York, United States, 10025 | |||||
United States, South Carolina | |||||
Julio Arroyo | |||||
West Columbia, South Carolina, United States, 29169 |
National Institute of Allergy and Infectious Diseases (NIAID) |
Hoffmann-La Roche |
Study Chair: | G Skowron |
Click here for more information about zidovudine 
  |
Study ID Numbers: | ACTG 047 |
First Received: | November 2, 1999 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00000718 |
Health Authority: | United States: Federal Government |
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