Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090779
Status:
TERMINATED
Last Update Posted:
2018-10-11
First Post:
2004-09-03
Brief Title:
Nine Month Course of Anti-HIV Medications for People Recently Infected With HIV
Sponsor:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Organization:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Study Overview
Official Title:
The SETPOINT Study - A Randomized Study of the Effect of Immediate Treatment With Potent Antiretroviral Therapy Versus Observation With Treatment as Indicated in Newly Infected HIV-1 Infected Subjects Does Early Therapy After the Virologic Setpoint
Status:
TERMINATED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The DSMB concluded that the findings regarding the primary analysis would persist and that no additional study goals would be achieved by continuing the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 long-term benefits or harm The purpose of this study is to learn whether or not people should take anti-HIV drugs when they are first infected
Detailed Description:
Combination antiretroviral therapy has resulted in significantly decreased morbidity and mortality incidence of opportunistic infections and hospitalizations in HIV infected people However because of long-term toxicities associated with long-term use of antiretrovirals and the persistence of virus in latent reservoirs it is unclear when it is best to initiate therapy in recently infected individuals This study compared the virologic outcomes of adults recently infected with HIV who received emtricitabinetenofovir disoproxil fumarate FTCTDF coformulated as Truvada and lopinavirritonavir LPVRTV coformulated as Kaletra immediate treatment IT arm with those who received no treatment deferred treatment DT arm
The original study lasted 96 weeks Participants were randomly assigned to one of two groups IT arm vs DT arm For the first 36 weeks of the study IT arm participants received FTCTDF once daily and LPVRTV twice daily Some IT arm participants received a different ART regimen as determined by the participant and study staff if appropriate DT arm participants received no treatment for the duration of the study At Week 37 participants from both arms were offered treatment continuation or initiation until Week 96 if they had a high viral load low CD4 count or experienced HIV-related symptoms Step 2 Study visits occurred at screening Weeks 1 2 4 8 12 16 20 24 28 32 36 37 38 40 and every 4 weeks thereafter Clinical assessment and blood collection occurred at all visits Urine tests occurred at selected visits Participants were asked to complete an adherence questionnaire at Weeks 12 24 and 36
Per the recommendations the DSMB review in June 2009 this protocol was terminated as originally written with the exception of those participants in the IT arm in the middle of the first 36 weeks of treatment Those participants were to continue on treatment until the end of the 36 weeks At that point treatment decisions were made on best practice guidelines In addition the study duration was extended to include a 5 year follow up of participants who did not initiate long-term antiretroviral therapy Step 3
The study was reviewed by an SMC on December 8 2010 The SMC recommended the study close to long term follow-up because only very few participants enrolled in this portion of the study
All the results except for the CD4 analysis and time to treatment initiation and deaths were based on the database frozen on July 2 2009 The results for the CD4 analysis and time to treatment initiation and deaths were based on the database frozen on January 30 2012
The original study lasted 96 weeks Participants were randomly assigned to one of two groups IT arm vs DT arm For the first 36 weeks of the study IT arm participants received FTCTDF once daily and LPVRTV twice daily Some IT arm participants received a different ART regimen as determined by the participant and study staff if appropriate DT arm participants received no treatment for the duration of the study At Week 37 participants from both arms were offered treatment continuation or initiation until Week 96 if they had a high viral load low CD4 count or experienced HIV-related symptoms Step 2 Study visits occurred at screening Weeks 1 2 4 8 12 16 20 24 28 32 36 37 38 40 and every 4 weeks thereafter Clinical assessment and blood collection occurred at all visits Urine tests occurred at selected visits Participants were asked to complete an adherence questionnaire at Weeks 12 24 and 36
Per the recommendations the DSMB review in June 2009 this protocol was terminated as originally written with the exception of those participants in the IT arm in the middle of the first 36 weeks of treatment Those participants were to continue on treatment until the end of the 36 weeks At that point treatment decisions were made on best practice guidelines In addition the study duration was extended to include a 5 year follow up of participants who did not initiate long-term antiretroviral therapy Step 3
The study was reviewed by an SMC on December 8 2010 The SMC recommended the study close to long term follow-up because only very few participants enrolled in this portion of the study
All the results except for the CD4 analysis and time to treatment initiation and deaths were based on the database frozen on July 2 2009 The results for the CD4 analysis and time to treatment initiation and deaths were based on the database frozen on January 30 2012
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 |
|---|---|---|---|
| 1U01AI068636 | NIH | None | None |
| AIEDRP AIN503 | None | None | None |
| ACTG A5217 | US NIH GrantContract | None | httpsreporternihgovquickSearch1U01AI068636 |