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Safety of AMD11070, a New Anti-HIV Drug, in HIV Uninfected Men Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Safety of AMD11070, a New Anti-HIV Drug, in HIV Uninfected Men conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety of AMD11070, a New Anti-HIV Drug, in HIV Uninfected Men Clinical research trials and Safety of AMD11070, a New Anti-HIV Drug, in HIV Uninfected Men healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Safety of AMD11070, a New Anti-HIV Drug, in HIV Uninfected Men. Safety of AMD11070, a New Anti-HIV Drug, in HIV Uninfected Men Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety of AMD11070, a New Anti-HIV Drug, in HIV Uninfected Men clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Safety of AMD11070, a New Anti-HIV Drug, in HIV Uninfected Men condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety of AMD11070, a New Anti-HIV Drug, in HIV Uninfected Men  Safety of AMD11070, a New Anti-HIV Drug, in HIV Uninfected Men
Safety of AMD11070, a New Anti-HIV Drug, in HIV Uninfected Men
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: Most currently approved anti-HIV drugs work by stopping the replication of HIV after it has entered cells. AMD11070 is designed to block HIV from entering cells and may be effective in treating patients who have developed resistance to or are unable to take other anti-HIV drugs. This study will evaluate the safety of different doses of AMD11070 in HIV uninfected men.
Details: Current therapy for HIV infection primarily uses drugs that inhibit HIV replication via inhibition of viral protease and reverse transcriptase. Many patients either do not tolerate these medications well or develop virologic failure due to incomplete viral suppression and development of antiviral resistance. New drugs target HIV entry into the cell. AMD11070 binds to the chemokine receptor CXCR4, inhibiting membrane fusion and viral entry. Animal studies have shown AMD11070 to be generally safe and well tolerated. This dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of AMD11070 in healthy, HIV uninfected male volunteers. Participants in this study will be assigned to either a single dose group (Group 1) or a multiple dose group (Group 2). Participants in the single dose group will be given AMD11070 once on an empty stomach (no food or drink except for water for 2 hours before and 1 hour after the drug). Up to four different doses will be tested in subgroups of Group 1 participants. Participants in Group 2 will be given AMD11070 seven times, 12 hours apart, on an empty stomach; three different doses will be tested in this group. All participants will be admitted to the hospital the evening before drug administration. Group 1 participants will be in the hospital for 24 hours; Group 2 participants will be in the hospital for 4 days. All participants will have multiple blood and urine tests throughout their hospital stay. Participants will have a follow-up study visit 2 weeks after discharge from the hospital. After completion of the initial part of the study, volunteers may be asked to participate in a second part of the study in which AMD11070 is taken after a meal.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Male
Protocol Entry Criteria: Inclusion Criteria: - HIV uninfected - Normal EKG and lab values - Body weight within 33% of ideal weight for height within 28 days of study entry - Willingness to refrain from exercise for 24 hours prior to study entry - Acceptable methods of contraception Exclusion Criteria - Previous participation in this study - Prescription medications, herbal supplements, or aspirin within 7 days of study entry - Nonsteroidal anti-inflammatory drugs, over-the-counter medications, and other supplements (including multivitamins) within 1 day of study entry - Active infection or acute illness within 14 days of study entry - Drug or alcohol abuse or dependence - History of gastrointestinal bleeding or ulcer - Any medical or psychological condition that, in the opinion of study officials, would interfere with study participation
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
CraigHendrix, Study Chair, Johns Hopkins University
University of Washington (Seattle) *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Coonley 206-731-8877
Johns Hopkins University *Recruiting*
Baltimore, Maryland, 21205
United States
Recruiting Ilene Wiggins 617-732-5635
Additional Information:
Study ID Numbers: ACTG A5191;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063804
Other Hiv Infections Studies:
1. A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 MN rsgp120 and Bivalent AIDSVAX B/E (HIV-1 MN rgp120/A244 rgp120) in Combination with QS-21 With or Without Alum in Healthy HIV-1 Uninfected Adults
2. Health Values and Spirituality in Veterans with HIV/AIDS
3. Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients
4. Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials
5. The Safety and Effects of 1592U89 Used Alone or in Combination with Other Anti-HIV Drugs in HIV-Infected Infants and Children
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Safety of AMD11070, a New Anti-HIV Drug, in HIV Uninfected Men
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