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A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes Clinical research trials and A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes health trials occur in a lot of 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 potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes. A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes clinical trial. Human subjects often get the best healthcare possible for their A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes  A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
For Condition: HIV Infections,HIV Seronegativity
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD),National Institute on Drug Abuse (NIDA),National Institute of Mental Health (NIMH)
Synopsis: Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM).
Details: Many studies have shown that prior HSV-2 infection is associated with an increased risk for HIV infection. Acyclovir is the most widely studied and clinically utilized antiviral for the suppression of HSV-2 infection. This study will evaluate the efficacy of twice-daily dosing of acyclovir in preventing HIV infection in both WSM and MSM with genital herpes. For this study, WSM will be enrolled in Lusaka, Zambia; Harare, Zimbabwe; and Johannesburg, South Africa; MSM will be enrolled in Lima and Pucallpa, Peru; Seattle, Washington, USA; New York City, New York, USA; and San Francisco, California, USA. Participants will be enrolled for 12 months in this study and will be randomly assigned to one of two study arms. The first arm will receive 400 mg acyclovir twice daily; the second arm will receive placebo. Follow-up visits will occur monthly. Participants will be tested for STDs, including HIV and syphilis, at each visit and treated as necessary; participants will also be given adherence and condom counseling, risk behavior and sexual history questionnaires, and genital symptoms questionnaires at all study visits. Medical history will be assessed and participants will undergo blood work at Months 3, 6, 9, and 12.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria For All Participants: - HIV uninfected - HSV-2 infected - Plans to stay in the area for the duration of study participation - Willing and able to provide consent, undergo clinical evaluations, take study drugs, adhere to follow-up schedule, and provide adequate locator information Inclusion Criteria for MSM: - At least 1 episode of anal intercourse with another man within 6 months of study entry Inclusion Criteria for WSM: - At least 1 episode of unprotected vaginal sex within 6 months of study entry Exclusion Criteria For All Participants: - Current enrollment in another HIV vaccine or prevention trial - History of adverse reaction to acyclovir - Current or planned use of famiciclovir, valacyclovir, or acyclovir for genital HSV. Use of short-course antiviral therapy for herpes zoster after enrollment is allowed. - Known plans for travel away from study site for more than 2 months Exclusion Criteria for MSM: - In a mutually monogamous relationship with an HIV uninfected partner throughout the past 2 years - Reported sex at birth as female Exclusion Criteria for WSM: - Pregnancy at screening or enrollment
Total Enrollment: 3682
Location and Contact Information:
Overall Study Official:
AnnaWald, Study Chair, University of Washington
Additional Information:
Study ID Numbers: HPTN 039;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076232
Other Hiv Infections Studies:
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2. A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients with Weakened Immune Systems
3. A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals
4. Acupressure to Treat Nausea and Vomiting in HIV/AIDS Patients
5. Immune restoration by lipoic acid in AIDS
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A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
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