Collection of Blood Samples From HIV Infected People
| Tracking Information | |||||
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| First Received Date ICMJE | November 15, 2004 | ||||
| Last Updated Date | October 26, 2012 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00096772 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 HIV Infected People | ||||
| Official Title ICMJE | Collection and Use of Blood For Genetic and Other Related Analyses (The GENOMICS Protocol) | ||||
| Brief Summary | The purpose of this study is to collect blood samples from HIV infected individuals for use in future genetic studies. |
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| Detailed Description | Genetic differences among people with HIV may account for differences in disease progression and response to antiretroviral therapy. The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) was created to conduct studies in HIV infected communities and particularly in people of color, women, and injection drug users. This study will collect whole blood samples from HIV infected individuals. The samples will be used in future CPCRA studies comparing human genetic factors with clinical data from other CPCRA studies. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Study participants will be selected from those who have given informed consent for participation in a qualifying CPCRA clinical trial. |
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| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 2503 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00096772 | ||||
| Other Study ID Numbers ICMJE | CPCRA 066 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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