A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time
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Purpose
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 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intermittent Foscarnet Therapy for Human Immunodeficiency Virus Infection in Patients Receiving Long-Term Zidovudine Therapy |
| Estimated Enrollment: | 12 |
| Study Completion Date: | June 1991 |
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| 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:
- 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.
Contacts and Locations| United States, Minnesota | |
| University of Minnesota, ACTU | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, North Carolina | |
| Unc Aids Crs | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Study Chair: | Jacobson MA |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001002 History of Changes |
| Other Study ID Numbers: | ACTG 053, 11027 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Drug Therapy, Combination Foscarnet Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Antiviral Agents Zidovudine |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Foscarnet Phosphonoacetic Acid |
Zidovudine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antimetabolites Anti-HIV Agents |
ClinicalTrials.gov processed this record on June 17, 2013