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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001002 |
To study the toxicity, pharmacokinetics, and antiretroviral effectiveness of combined oral zidovudine (AZT) and intermittent intravenous foscarnet therapy in stable AIDS or AIDS related complex (ARC) patients who have already received AZT for 8 - 52 weeks.
It is hypothesized that the maximum AZT antiretroviral effect, which occurs at 8 weeks of therapy, will be enhanced by 2 weeks of foscarnet treatment, given at the same time by intermittent intravenous infusion. In addition, the further lowering of serum p24 antigen concentration that should occur during combined therapy might continue when oral AZT therapy is continued without foscarnet.
Condition | Intervention | Phase |
HIV Infections |
Drug: Zidovudine Drug: Foscarnet sodium |
Phase I |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Zidovudine Foscarnet Foscarnet sodium Fosfonet sodium Phosphonoacetic acid |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Intermittent Foscarnet Therapy for Human Immunodeficiency Virus Infection in Patients Receiving Long-Term Zidovudine Therapy |
Estimated Enrollment: | 12 |
It is hypothesized that the maximum AZT antiretroviral effect, which occurs at 8 weeks of therapy, will be enhanced by 2 weeks of foscarnet treatment, given at the same time by intermittent intravenous infusion. In addition, the further lowering of serum p24 antigen concentration that should occur during combined therapy might continue when oral AZT therapy is continued without foscarnet.
There is a 4-week prestudy monitoring period during which AZT alone is administered on an outpatient basis, followed by a 2-week study period during which both intravenous foscarnet and oral AZT are administered in the hospital. During the subsequent 6-month follow-up period, oral AZT is administered and patients receive clinical evaluations. AZT is held for 48 hours on days before hospitalization and for 24 hours at the end of the hospitalization.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Medication necessary for the patient's welfare at the discretion of the investigator.
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following will be excluded:
Concurrent Medication:
Excluded:
Patients with the following will be excluded:
United States, California | |||||
San Francisco AIDS Clinic / San Francisco Gen Hosp | |||||
San Francisco, California, United States, 941102859 | |||||
Los Angeles County - USC Med Ctr | |||||
Los Angeles, California, United States, 90033 | |||||
USC School of Medicine / Norris Cancer Hosp | |||||
Los Angeles, California, United States, 90033 | |||||
United States, North Carolina | |||||
Univ of North Carolina | |||||
Chapel Hill, North Carolina, United States, 275997215 |
Study Chair: | Jacobson MA |
Click here for more information about Zidovudine 
  |
Study ID Numbers: | ACTG 053 |
First Received: | November 2, 1999 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00001002 |
Health Authority: | United States: Federal Government |
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