Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084032
Status:
WITHDRAWN
Last Update Posted:
2012-10-29
First Post:
2004-06-04
Brief Title:
Anti-HIV Medications and Structured Treatment Interruptions for People Recently Infected With HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Multicenter Trial to Determine Whether Induction Therapy Followed by Treatment Interruption is Superior to Induction Therapy Alone in the Treatment of Primary HIV Infection PHI The Structured Treatment Interruption STI Study
Status:
WITHDRAWN
Status Verified Date:
2012-10
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:
People recently infected with HIV who are treated with anti-HIV medications may develop strong immune system responses to HIV and may be able to control the virus without continuing to take these medications The purpose of this study is to see if giving anti-HIV medications to people soon after they have been infected with HIV can help them control HIV The study will also see if the immune system can control the amount of HIV virus in the blood viral load even after a person has stopped taking the medications The study will evaluate three different schedules of stopping and starting anti-HIV medications to see which schedule is best able to boost a patients immune system to control HIV viral load
Hypothesis Combination therapy started in primary HIV infection in conjunction with structured treatment interruptions will result in greater control of viremia off treatment than induction therapy alone
Hypothesis Combination therapy started in primary HIV infection in conjunction with structured treatment interruptions will result in greater control of viremia off treatment than induction therapy alone
Detailed Description:
Initiation of treatment during acute HIV infection seems to result in greater suppression of viral replication than noted during chronic infection and better recovery of certain CD4 subpopulations However it is difficult for patients treated during acute infection to maintain long-term continuous antiretroviral ARV treatment because of difficulty adhering to complicated medication regimens drug-related toxicities and cost of medications Acutely infected patients who have undergone early initiation of treatment followed by structured treatment interruptions STIs appear to have lower off-treatment viral loads than historical controls This study will evaluate whether effective ARV treatment during acute and early HIV infection followed by STI will result in lower viral setpoints than would otherwise be expected
This trial will have 2 steps and will last for a maximum of 104 weeks Participants will either enter Step 1 and continue on to Step 2 or enter Step 2 directly During Step 1 participants with acute or early HIV infection will be given 24 weeks of ARV therapy Participants may take any combination of FDA-approved ARV medications that they and their doctors select Participants will have study visits at study entry and Weeks 1 4 8 and 20 After 24 weeks on Step 1 participants may enroll in Step 2
Participants in Step 1 and people with early or acute HIV infection who began ARV treatment within 21 days of diagnosis and have had no more than 1 year of treatment may enroll in Step 2 During Step 2 participants will be randomly assigned to one of two study arms
Arm 1 Participants will continue taking ARV therapy for 16 weeks and then stop ARVs for 64 weeks
Arm 2 Participants will stop ARVs for 4 weeks take ARVs for 8 weeks stop ARVs for 4 weeks take ARVs for 8 weeks and then stop ARVs for 56 weeks
Participants in both study arms will restart ARVs regardless of STI duration if their viral load is above 50000 copiesml they progress to CDC category C disease or their CD4 count falls below 350 cellsmm3 or declines more than 50 from the last on-treatment CD4 level
Step 2 will last 80 weeks For the first year participants will have study visits every 1 to 4 weeks depending on whether they are taking ARVs During the second year participants will have study visits every 8 weeks Study visits will include a brief medical history blood and pregnancy tests and voluntary behavioral questionnaires
This trial will have 2 steps and will last for a maximum of 104 weeks Participants will either enter Step 1 and continue on to Step 2 or enter Step 2 directly During Step 1 participants with acute or early HIV infection will be given 24 weeks of ARV therapy Participants may take any combination of FDA-approved ARV medications that they and their doctors select Participants will have study visits at study entry and Weeks 1 4 8 and 20 After 24 weeks on Step 1 participants may enroll in Step 2
Participants in Step 1 and people with early or acute HIV infection who began ARV treatment within 21 days of diagnosis and have had no more than 1 year of treatment may enroll in Step 2 During Step 2 participants will be randomly assigned to one of two study arms
Arm 1 Participants will continue taking ARV therapy for 16 weeks and then stop ARVs for 64 weeks
Arm 2 Participants will stop ARVs for 4 weeks take ARVs for 8 weeks stop ARVs for 4 weeks take ARVs for 8 weeks and then stop ARVs for 56 weeks
Participants in both study arms will restart ARVs regardless of STI duration if their viral load is above 50000 copiesml they progress to CDC category C disease or their CD4 count falls below 350 cellsmm3 or declines more than 50 from the last on-treatment CD4 level
Step 2 will last 80 weeks For the first year participants will have study visits every 1 to 4 weeks depending on whether they are taking ARVs During the second year participants will have study visits every 8 weeks Study visits will include a brief medical history blood and pregnancy tests and voluntary behavioral questionnaires
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