A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases
Completed · Not applicable
Conditions studied: AIDS Dementia Complex, Neuromuscular Diseases, HIV Infections
In brief
The purpose of this pilot study is to evaluate the efficacy of Retrovir (AZT) in the treatment of AIDS-related dementia and various neuromuscular complications. HIV is both a lymphotropic and neurotropic virus which can affect both the central and peripheral nervous systems (CNS, PNS). There is evidence that the CNS and PNS may harbor the virus in a latent state, with the potential for continuous reinfection of other body systems. Therefore, effective therapeutic efforts against HIV infection should provide effective antiviral activity within the nervous system.
Key facts
- Study ID
- NCT00002044
- Run by
- Glaxo Wellcome
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Co-existing Condition:
- Patients with the following are excluded:
- Past or present renal disease.
- Significant bone marrow suppression.
- Blood transfusion within the past month.
- Liver dysfunction.
- Evidence of an underlying, severe infection.
- Evidence of an active life-threatening opportunistic infection at study entry.
- Severe malabsorption (patients with recent significant weight loss must have a serum carotene level of > 75 IU/ml).
- Evidence of nervous system dysfunction being caused by factors other than HIV infection, particularly by cerebral toxoplasmosis, lymphoma, cryptococcal meningitis, chronic alcohol abuse, lead poisoning, cytomegalovirus (CMV) infection (patients with retinal CMV infection or other evidence of CMV dementia), syphilis, or progressive multifocal leukoencephalopathy.
- Other known causes of nerve or muscle disease.
- Hypersensitivity to zidovudine (AZT).
- Lymphoma or other tumor requiring cytotoxic chemotherapy.
- Concurrent Treatment:
- Allowed:
- Electron beam therapy to an area of less than 100 cm2.
- Patients with the following are excluded:
- Past or present renal disease.
- Significant bone marrow suppression.
- Blood transfusion within the past month.
- Liver dysfunction.
- Evidence of an underlying, severe infection.
- Evidence of an active life-threatening opportunistic infection at study entry.
- Severe malabsorption (patients with recent significant weight loss must have a serum carotene level of > 75 IU/ml).
- Evidence of nervous system dysfunction being caused by factors other than HIV infection, particularly by cerebral toxoplasmosis, lymphoma, cryptococcal meningitis, chronic alcohol abuse, lead poisoning, cytomegalovirus (CMV) infection (patients with retinal CMV infection or other evidence of CMV dementia), syphilis, or progressive multifocal leukoencephalopathy.
You may not qualify if…
- Concurrent Medication:
- Excluded:
- Cytotoxic chemotherapy.
- Steroids.
- Interferon.
- Immunomodulating agents.
- Concurrent Treatment:
- Excluded:
- Radiation therapy (except electron beam therapy to an area of less than 100 cm2).
- Prior Medication:
- Excluded within 4 weeks of study entry:
- Cytotoxic chemotherapy.
- Any retroviral drug including but not limited to zidovudine (AZT), ribavirin, HPA 23, AL721, or phosphonoformate.
- Steroids.
- Interferon.
- Immunomodulating agents.
- An anticipated need for any of these agents within the next 16 weeks.
- Prior Treatment:
- Excluded within 1 month of study entry:
- Radiation therapy (except electron beam therapy to an area of less than 100 cm2).
- Blood transfusion.
Where it is running
- Glaxo Wellcome Inc — Research Triangle Park, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.