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| Tracking Information | |||||||||||||||||||||||||||||
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| First Received Date ICMJE | November 2, 1999 | ||||||||||||||||||||||||||||
| Last Updated Date | September 25, 2008 | ||||||||||||||||||||||||||||
| Start Date ICMJE | March 2007 | ||||||||||||||||||||||||||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00001092 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||||||
| Brief Title ICMJE | The Biology of HIV Transmission | ||||||||||||||||||||||||||||
| Official Title ICMJE | The Determinants of the Biology of HIV Transmission to Determine the Immunologic and Virologic Characteristics of Those Who May Have Transmitted HIV to Another Individual | ||||||||||||||||||||||||||||
| Brief Summary | The purpose of this study is to look at the amount of HIV in the blood, genital fluid, and saliva of the partners of patients with early HIV infection. This study will also look at the strength of the immune systems of patients with early HIV infection. Because HIV multiplies very quickly in the early stages of infection, patients with early HIV infection may be more likely to transmit HIV to their partners. The amount of HIV in blood, genital fluid, and saliva may determine the risk for transmission. |
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| Detailed Description | Persons with early HIV infection may represent high transmission risk to their partners. Early infection, characterized by rapid virologic replication, insufficient immunologic control of infection, and more rapid course of disease progression, may be associated with increased infectiousness. The viral determinants of transmission may in part be explained by viral burden in blood, genital fluids, and oral cavity fluids. All three fluids may be the source for transmitted virus. Persons with suspected HIV infection are asked to identify their possible source partners. The importance of partner referral is emphasized and assisted recruitment or active tracing is offered if necessary. Source partners will not be approached uninvited. If a partner states that he/she does not want to be contacted, then he/she will not be contacted further for the purpose of this study or for any other study. All patients are offered HIV counseling and plasma testing for HIV-1 RNA and CD4+ cells. Blood specimens are collected for plasma determination, and cellular and plasma fractions are collected for CAF and neutralization antibodies. Neutralization assays are used to detect humoral immune response in patients with primary HIV infection. Genital fluids and saliva are analyzed for viral RNA. Patients are seen in the clinic on Day 1 for blood draw and return 2 weeks later for blood test results. A follow-up period of at least 4 weeks is planned. Compensation is provided to all patients. |
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| Study Phase | |||||||||||||||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||||||||||||||
| Study Design ICMJE | Cohort, Prospective | ||||||||||||||||||||||||||||
| Condition ICMJE | HIV Infections | ||||||||||||||||||||||||||||
| Intervention ICMJE | |||||||||||||||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||||||||||||||
| Publications * | |||||||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||||||||||||||||||||||
| Completion Date | |||||||||||||||||||||||||||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria Patients may be eligible for this study if they:
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| Gender | Both | ||||||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||||||||||||||
| Contacts ICMJE | |||||||||||||||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||
| NCT ID ICMJE | NCT00001092 | ||||||||||||||||||||||||||||
| Responsible Party | Rona Siskind, DAIDS | ||||||||||||||||||||||||||||
| Study ID Numbers ICMJE | AIEDRP AI-05-007, UCSD Project 98-0776, AEHIV 007 | ||||||||||||||||||||||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||||||||||||||||||
| Collaborators ICMJE | |||||||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||||||||||||||||||
| Verification Date | September 2008 | ||||||||||||||||||||||||||||
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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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