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SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir Clinical research trials and SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir. SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir clinical trial. Test subjects typically receive the most expert healthcare available for their SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir  SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir
SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir
For Condition: Herpes Simplex,HIV Infections
Status: Completed
Sponsor(s): Shaman Pharmaceuticals ,
Synopsis: To evaluate the safety and tolerance of topically applied SP-303T in AIDS patients. To observe the effect of this drug on herpes simplex virus lesions in patients who have failed to heal in response to oral or intravenous acyclovir therapy. The lack of alternative treatments for herpes simplex virus infection in patients with AIDS and the development of resistance to acyclovir for patients requiring repeated treatment presents a therapeutic dilemma for physicians. SP-303T has good in vitro activity against resistant strains and offers a convenient and inexpensive means of drug administration in comparison to the use of intravenous medication.
Details: The lack of alternative treatments for herpes simplex virus infection in patients with AIDS and the development of resistance to acyclovir for patients requiring repeated treatment presents a therapeutic dilemma for physicians. SP-303T has good in vitro activity against resistant strains and offers a convenient and inexpensive means of drug administration in comparison to the use of intravenous medication. Patients receive 14 days (and up to 42 days) of treatment with topically applied SP-303T. SP-303T is applied directly onto herpes simplex virus lesions three times daily in a quantity sufficient to thinly cover the entire lesion, which may then be covered with an appropriate dressing, if needed. At the end of the treatment period, patients enter a follow-up period of 2 weeks.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV-1 infection. - AIDS. - Chronic mucocutaneous herpes simplex virus (HSV) infection, with one or more lesions unresponsive to oral acyclovir therapy. - No uncontrolled infections other than HSV. - Sufficient mental status to understand the purpose of the study and to comply with study requirements. - Sufficient general health to be an outpatient and to come to the clinic for required follow-up visits. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Known hypersensitivity or allergy to citrus fruits, black currant berries, and rose hips. - Any disease condition that, in the opinion of the investigator, would interfere with evaluation of the study drug, affect patient compliance, or place the patient at increased risk. Concurrent Medication: Excluded: - Other unapproved investigational new drugs. - Concurrent other therapy for herpes simplex virus (HSV) infection or medications with known activity against HSV. Required: - A minimum of 10 days of prior oral acyclovir (at least 1 g daily) or 10 days of prior intravenous acyclovir (15 mg/kg daily).
Total Enrollment:
Location and Contact Information:
TheraFirst Med Ctrs Inc
Ft. Lauderdale, Florida, 33308
United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
United States
Additional Information:
Study ID Numbers: 120A; SP303T-A-01
Study Start Date:
Record last reviewed: September 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002310
Other Hiv Infections Studies:
1. Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
2. A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
3. A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes
4. A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
5. Continuous High-Dose Intravenous Dextran Sulfate in Human Immunodeficiency Virus-Infected Individuals
Related Studies:
Other HIV Infections Clinical Trials
Other Utah Clinical Trials
Other Salt Lake City Clinical Trials
SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir
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