Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106171
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2005-03-21
Brief Title:
Anti-HIV Medications for People Recently Infected With HIV
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
A Randomized Trial of HAART in AcuteEarly HIV Infection
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is not known if anti-HIV treatment for recently infected patients improves long-term patient prognosis The purpose of this study is to determine if a one year course of anti-HIV medications slows progression of HIV disease in adults recently infected with HIV
Study hypothesis A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection
Study hypothesis A one-year course of HAART administered during acute or early seroconversion may slow the progression of HIV infection
Detailed Description:
Although some doctors favor starting anti-HIV treatment as soon as possible after patients learn they are infected it is not known if treatment for recently infected patients results in slower progression of HIV disease This study will compare the virologic outcomes of recently infected adults who receive highly active antiretroviral therapy HAART with those who receive no treatment This study will also compare the effects of treatment on patients who enroll within 3 months of seroconversion acute seroconverters with patients who enroll within 3 to 12 months of seroconversion early seroconverters
This study will last at least 3 years Participants will be randomly assigned to one of two groups Group 1 will receive HAART for 1 year Group 2 will receive no treatment There will be at least 20 study visits over the 3-year study period Blood collection will occur at all study visits A physical exam medical and medication history and risk behavior assessment will occur at most visits participants will also be asked to complete an adherence questionnaire at most visits
This study will last at least 3 years Participants will be randomly assigned to one of two groups Group 1 will receive HAART for 1 year Group 2 will receive no treatment There will be at least 20 study visits over the 3-year study period Blood collection will occur at all study visits A physical exam medical and medication history and risk behavior assessment will occur at most visits participants will also be asked to complete an adherence questionnaire at most visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AI056990-01A1 | NIH | None | httpsreporternihgovquickSearch1R01AI056990-01A1 |