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Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS) conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS) Clinical research trials and Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS) healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS). Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS) clinical trial. Participants typically obtain the most effective healthcare available for their Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS) condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS) Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS)
Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS)
For Condition: Herpes Simplex,HIV Infections
Status: Completed
Sponsor(s): Shaman Pharmaceuticals ,
Synopsis: To evaluate the safety of topically applied SP-303 gel and to compare the efficacy of SP-303 gel in combination with acyclovir, relative to acyclovir alone, for the treatment of recurrent Herpes Simplex Virus (HSV) 1 and 2 infections, affecting the genital, perianal and neighboring areas, in patients with AIDS.
Details: This trial is a double-blind, multicenter, placebo-controlled clinical trial. Participants are randomized to topical 15% SP-303 gel and oral acyclovir or to matching topical placebo gel and oral acyclovir. At presentation, patients are stratified by total lesion area within each treatment group. SP-303 or matching placebo is topically applied three times a day until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Acyclovir is administered by mouth each day, three times a day, until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Patients are evaluated for lesion healing and adverse events 3 times per week during the treatment period. The primary efficacy endpoint will be complete lesion healing and the primary analysis will be time to complete healing.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - AIDS, according to the CDC criteria. - Documented recurrent (at least 1 prior episode) perineal (genital, perianal and neighboring areas) mucocutaneous herpes simplex virus (HSV) types 1 or 2 infection in the active phase. - Duration of current episode of recurrent HSV lesions of 3 days or less. - Ability to read and write, must be intellectually competent, and able to understand the purposes and risks of the study. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Active internal anal or rectal herpes. - Inability to comply with protocol. - Impaired renal function. Patients with the following prior conditions are excluded: - Prior episode of recurrent genital herpes infection with documented clinical failure of acyclovir as a treatment regimen. - Uncompensated hepatic, cardiac, or renal failure within 1 month of the study. - History of hypersensitivity to acyclovir. - Previous enrollment in this study. 1. Treatment with another medication (topical, oral, or intravenous) with known anti-HSV activity within the past 5 days. - Systemic immunomodulatory therapy within 30 days prior to study. - Previous treatment with SP-303. Required: Unchanged antiretroviral therapy for the 2 weeks prior to study.
Total Enrollment: 400
Location and Contact Information:
Hill Top Research Ltd
Scottsdale, Arizona, 85251
United States
Medicine / Infectious Diseases
Minneapolis, Minnesota, 55455
United States
Saint Agnes Healthcare / Dept of Surgery
Baltimore, Maryland, 21229
United States
Conant Med Ctr
San Francisco, California, 94117
United States
Veterans Affairs Med Ctr of North Chicago
Chicago, Illinois, 60064
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Washington Virology Research Clinic
Seattle, Washington, 98122
United States
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712
United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219
United States
Gary Richmond MD
Ft. Lauderdale, Florida, 33316
United States
Novum Inc
Seattle, Washington, 98122
United States
Division of Infectious Diseases / Univ of Texas - Houston
Houston, Texas, 77030
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Paddington Testing Co Inc
Philadelphia, Pennsylvania, 19103
United States
Novum Inc
Washington D.C., District of Columbia, 20037
United States
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Dr Robert Holman
Arlington, Virginia, 22205
United States
ViRx Inc
Palm Springs, California, 92262
United States
Austin Infectious Disease Consultants
Austin, Texas, 78705
United States
Summit Med Ctr / Adult Immunology Clinic
Oakland, California, 94609
United States
Dermatology SVC - VAMC
Long Beach, California, 90822
United States
AIDS Ctr / Saint Vincents Hosp and Med Ctr
New York City, New York, 10011
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
King - Drew Med Ctr / Dept of Dermatology
Los Angeles, California, 90059
United States
Massachusetts Gen Hosp - Warren 505
Boston, Massachusetts, 02114
United States
Hosp Regional de Ponce - Area Vieja
Ponce, , 00731
Puerto Rico
Dr Robert Schwartz
Ft. Myers, Florida, 33901
United States
ViRx Inc
San Francisco, California, 94109
United States
Sorra Research Ctr Inc / Med Forum
Birmingham, Alabama, 35203
United States
New York Univ Med Ctr
New York City, New York, 10016
United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
United States
San Juan AIDS Program
Santurce, , 00908
Puerto Rico
Johns Hopkins Univ / Division of Infectious Disease
Baltimore, Maryland, 21205
United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
United States
Additional Information:
Study ID Numbers: 270A; 96-867-DE
Study Start Date:
Record last reviewed: February 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002186
Other Hiv Infections Studies:
1. A Comparison of ISIS 2922 Used Immediately or Later in Patients with Cytomegalovirus (CMV) of the Eyes
2. An Open Trial Combining Zidovudine, Interferon-alfa, and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection
3. A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success with Other Anti-HIV Drugs
4. A simplified Kaletra® (lopinavir/ritonavir)-based therapy versus a Sustiva® (efavirenz)-based standard of care in previously non-treated HIV-infected subjects
5. Safety and Effectiveness of Adding Either an HIV Vaccine, Interleukin-2, or Both to a Patient's Anti-HIV Drug Combination
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Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS)
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