Treatment of Acute HIV Infection to Preserve Immune Function
| Tracking Information | |||||
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| First Received Date ICMJE | February 19, 2003 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | July 1999 | ||||
| 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 NCT00055094 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 | Treatment of Acute HIV Infection to Preserve Immune Function | ||||
| Official Title ICMJE | Immune Control of HIV Replication | ||||
| Brief Summary | While most people with HIV experience significant destruction of their immune systems, some people appear to have preserved immune function and can control the virus without drugs. Early treatment with anti-HIV drugs may help preserve the immune system, allowing it to control the virus once the drugs are stopped. This study will evaluate the immune system response of HIV infected people who are treated with anti-HIV drugs soon after being infected. |
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| Detailed Description | Studies have identified a potent CD4 T helper (Th) cell response in some infected people, and have shown a correlation between virus-specific Th cells and low levels of viremia. Early institution of potent antiviral therapy in the earliest stages of acute HIV infection have led to strong Th cell responses, analogous to those seen in people who are able to control viremia in the absence of antiviral therapy. This may be because potent antiviral therapy is able to protect virus-specific Th cells as they become activated, and thus these cells are not lost in the earliest stages of infection. This study will characterize the immune response of patients with acute HIV infection who receive antiretroviral therapy and will determine the effects of interruption of therapy in those people who have immune responses to HIV that are similar to patients with long-term non-progressing infection. Participants in this study will be followed through June 2004. Study visits vary from only once to every month and are scheduled at the discretion of the study officials. Study visits include an interview and blood tests. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
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| 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 | ||||
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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 | Completed | ||||
| Enrollment ICMJE | 500 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria
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| Gender | Both | ||||
| Ages | 18 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 | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00055094 | ||||
| Other Study ID Numbers ICMJE | 1R01AI44656-01, 5R01AI044656-04 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| 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 | April 2004 | ||||
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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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