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A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time Clinical research trials and A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time. A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time  A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time
A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: Medication necessary for the patient's welfare at the discretion of the investigator. Patients must have the following: - Received zidovudine (AZT) 200 mg every 4 hours (q4h) continuously for 8 - 16 weeks without Grade 3 or higher toxicity. - Detectable p24 antigen in serum on at least 2 occasions during the prestudy period. All serum p24 antigen concentrations measured during the prestudy period must be at least twice the concentration cutoff value of the assay. - Capability of giving informed consent. - Per amendment of 890721, patients must enter the study period by September 30, 1989. Exclusion Criteria Co-existing Condition: Patients with the following will be excluded: - A history of hypersensitivity reaction to foscarnet or zidovudine (AZT). - History of Grade 3 or 4 toxicity with AZT. - Current Grade 2 or higher AZT toxicity. - Osteomalacia, neoplasm metastatic to bone, or other known bone disease. - Active opportunistic infection requiring myelosuppressive or nephrotoxic therapy. Concurrent Medication: Excluded: - Antimetabolites. - Immunomodulators. - Nephrotoxins. - Antiviral therapy. - Myelosuppressive or nephrotoxic therapy. - Acetaminophen. Patients with the following will be excluded: - A history of hypersensitivity reaction to foscarnet or zidovudine (AZT). - History of Grade 3 or 4 toxicity with AZT. - Current Grade 2 or higher AZT toxicity. - Osteomalacia, neoplasm metastatic to bone, or other known bone disease. - Active opportunistic infection requiring myelosuppressive or nephrotoxic therapy.
Total Enrollment: 12
Location and Contact Information:
Overall Study Official:
JacobsonMA, Study Chair,
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
USC School of Medicine / Norris Cancer Hosp
Los Angeles, California, 90033
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Additional Information:
Study ID Numbers: ACTG 053;
Study Start Date:
Record last reviewed: September 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001002
Other Hiv Infections Studies:
1. Comparison of Three Treatments for Pneumocystis Pneumonia in AIDS Patients
2. The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children
3. Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.
4. Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities
5. A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
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A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time
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