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Study Of Safety And Tolerability Of A Regimen Combining One Investigational Compound With Other FDA Approved HIV Drugs 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 Study Of Safety And Tolerability Of A Regimen Combining One Investigational Compound With Other FDA Approved HIV Drugs conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Study Of Safety And Tolerability Of A Regimen Combining One Investigational Compound With Other FDA Approved HIV Drugs Clinical research trials and Study Of Safety And Tolerability Of A Regimen Combining One Investigational Compound With Other FDA Approved HIV Drugs 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 Study Of Safety And Tolerability Of A Regimen Combining One Investigational Compound With Other FDA Approved HIV Drugs. Study Of Safety And Tolerability Of A Regimen Combining One Investigational Compound With Other FDA Approved HIV Drugs 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 Study Of Safety And Tolerability Of A Regimen Combining One Investigational Compound With Other FDA Approved HIV Drugs clinical trial. Human subjects often get the best healthcare possible for their Study Of Safety And Tolerability Of A Regimen Combining One Investigational Compound With Other FDA Approved HIV Drugs 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 > "S" Clinical Trials Conditions > Study Of Safety And Tolerability Of A Regimen Combining One Investigational Compound With Other FDA Approved HIV Drugs  Study Of Safety And Tolerability Of A Regimen Combining One Investigational Compound With Other FDA Approved HIV Drugs
Study Of Safety And Tolerability Of A Regimen Combining One Investigational Compound With Other FDA Approved HIV Drugs
For Condition: HIV Infections
Status: Completed
Sponsor(s): Sponsor Name Pending ,
Synopsis: Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study to test the safety and tolerability of one investigational drug in combination with other marketed HIV products. Subjects will receive 24 weeks of therapy.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: (All of these criteria must be met in order to be eligible to participate in this study) - 1. Lab result for Screening viral load (HIV-1 RNA) greater than or equal to 1,000 copies per mL. - 2. Lab result for Screening CD4 cell count greater than or equal to 100 cells per microliter. - 3. Antiretroviral therapy naive (no prior therapy allowed). - 4. Male or female 13 years of age or older (or 18 years of age or older according to local requirements). - 5. Female subjects must be of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including women who are post-menopausal) or of child-bearing potential with a negative blood pregnancy test at screen and who agree to use a proven barrier method of contraception (e.g. spermicide plus condom) during the study period. Hormonal contraceptives will not be considered sufficient forms of contraception for this study. All subjects participating in this study should be counselled on the practice of safe or safer sex. - 6. Able to understand and provide written informed consent to participate in this trial. Parental or guardian consent must also be obtained for subjects under the age of 18 years. Exclusion Criteria: (NONE of these criteria can be met in order to be eligible for this study.) - 1. Prior history of having received antiretroviral therapy. - 2. An active HIV Associated Disease (Center for Disease Control Category C) within 28 days of study drug administration. - 3. Any sudden onset or sharp rise in a laboratory abnormality (including abnormally high laboratory values) at Screening that causes the investigator to have the opinion that the subject should not participate in the study of an investigational compound. - 4. Subjects with a laboratory result for estimated creatinine clearance less than 40 ml per minute within 28 days of study drug administration. - 5. Laboratory result for serum aminotransferase (AST, ALT) levels elevated greater than five to ten times (or more) the upper limit of the normal range within 28 days prior to study drug administration. - 6. Pregnant or lactating women. - 7. History of clinically relevant pancreatitis or hepatitis within 6 months of study drug administration. - 8. Presence of any serious medical condition (e.g., diabetes, cardiac dysfunction, hepatitis) which, in the opinion of the investigator, might compromise the safety of the subject. - 9. Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the subject unable to take oral medication. - 10. History of a drug or other allergy which, in the opinion of the investigator, contraindicates the subject's participation in the study. - 11. Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days of study drug administration or anticipated need for such treatment during the study. - 12. Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days of study drug administration. - 13. Treatment with any HIV vaccine within 3 months of study drug administration. - 14. Treatment with other selected medications within 28 days prior to receiving study medication or the anticipated need during the study. - 15. Current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subject's ability to comply with the requirements of the study. Note: Subjects stabilized on methadone can be considered for participation. - 16. Treatment with other investigational drugs or therapies within 28 days prior to Day 1, or an anticipated need for such treatment during the study. Treatments available through a Treatment IND or other expanded-access mechanism will be evaluated on a case-by-case basis. - 17. Other inclusion or exclusion criteria to be determined by the investigator and sponsor of the study.
Total Enrollment:
Location and Contact Information:
Study Site
Long Beach, California, 90813
United States
Study Site
London, , SE5 9RS
United Kingdom
Study Site
Ft. Lauderdale, Florida, 33306
United States
Study Site
Ft. Lauderdale, Florida, 33316
United States
Study Site
Denver, Colorado, 80220
United States
Study Site
Lyon, , 69437
France
Study Site
Atlanta, Georgia, 30339
United States
Study Site
Newport Beach, California, 92663
United States
Study Site
Philadelphia, Pennsylvania, 19107
United States
Study Site
Paris, , 75475
France
Study Site
Greenville, North Carolina, 27858
United States
Study Site
Altamonte Springs, Florida, 32701
United States
Study Site
Ft. Lauderdale, Florida, 33311
United States
Study Site
Little Rock, Arkansas, 72205
United States
Study Site
Manchester, , M8 6RL
United Kingdom
Study Site
San Diego, California, 92101
United States
Study Site
Washington D.C., District of Columbia, 20037
United States
Study Site
Paris, , 75679
France
Additional Information:
Study ID Numbers: AZL30006;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043888
Other Hiv Infections Studies:
1. The Effect of Anti-HIV Therapy on Fat Metabolism in HIV-Positive Patients
2. Analysis of Immune Responses to HIV Vaccines
3. A Study of Zidovudine Plus Interleukin-2 in HIV-Infected Patients Who Have No Symptoms of Infection But Who Have Tender Lymph Nodes
4. A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers
5. Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis
Related Studies:
Other HIV Infections Clinical Trials
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Study Of Safety And Tolerability Of A Regimen Combining One Investigational Compound With Other FDA Approved HIV Drugs
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