Collection of Blood Samples From SMART Study Participants for Future Genetic Studies
Recruitment status was Active, not recruiting
| Tracking Information | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 14, 2006 | ||||||||||||||||||||
| Last Updated Date | November 9, 2007 | ||||||||||||||||||||
| Start Date ICMJE | Not Provided | ||||||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00377169 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Collection of Blood Samples From SMART Study Participants for Future Genetic Studies | ||||||||||||||||||||
| Official Title ICMJE | Genomics: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study) | ||||||||||||||||||||
| Brief Summary | The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies. |
||||||||||||||||||||
| Detailed Description | Despite progress in the treatment of HIV and a greater understanding of the pathophysiology of HIV infection, there are still unexplained differences in both the progression of untreated HIV infection and response to antiretroviral therapy. These differences are likely related to the unique genetic makeup of individuals with HIV infection. Particular genes may offer protection against HIV infection, while other genes may make disease progression more likely. Knowing more about the genetic makeup of HIV infected individuals may lead to the development of a targeted treatment strategy based on an individual's specific risk of disease progression and sensitivity to medication toxicity. The purpose of this substudy is to collect blood samples from SMART study participants. The samples will be used in future Community Programs for Clinical Research on AIDS (CPCRA) studies investigating the link between human genetic factors and clinical outcome data. This study will enroll individuals currently participating in the SMART study. Participants will provide one blood sample. Individual test results from future blood analyses will not be provided to a patient unless they may have profound health implications for that patient. |
||||||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||||||
| Study Design ICMJE | Not Provided | ||||||||||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||||||||
| Sampling Method | Not Provided | ||||||||||||||||||||
| Study Population | Not Provided | ||||||||||||||||||||
| Condition ICMJE | HIV Infections | ||||||||||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||||||
| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 3261 | ||||||||||||||||||||
| Completion Date | Not Provided | ||||||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||||||||||||||||||
| Gender | Both | ||||||||||||||||||||
| Ages | 13 Years and older | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
| Location Countries ICMJE | United States, American Samoa, Australia, Belgium, Canada, Chile, Denmark, Finland, Gambia, Germany, Japan, Morocco, New Zealand, Poland, Portugal, Uruguay | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT00377169 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | CPCRA 065H, SMART | ||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||
| Responsible Party | Not Provided | ||||||||||||||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||||||||||
| Collaborators ICMJE | Community Programs for Clinical Research on AIDS | ||||||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||||||
| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||||||||||
| Verification Date | September 2006 | ||||||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||||||