Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100646
Status:
COMPLETED
Last Update Posted:
2014-08-27
First Post:
2005-01-04
Brief Title:
Anti-HIV Treatment Interruptions in HIV Infected Adults in South Africa
Sponsor:
The Wistar Institute
Organization:
The Wistar Institute
Study Overview
Official Title:
A Randomized Clinical Trial Assessing Continuous HAART Versus Interrupted HAART in a Resource Poor Clinic
Status:
COMPLETED
Status Verified Date:
2013-11
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:
HIV infected people often must take anti-HIV drugs for long periods leading to long-term drug exposure and toxicity Interruptions in anti-HIV therapy also known as structured treatment interruptions STIs may have few negative health effects and may be helpful to the overall long-term health of HIV-infected people The purpose of this study is to determine if sequential short-term STIs of antiretroviral therapy ART in HIV infected individuals in a resource-constrained environment can retain the immune reconstitution benefits of continuous treatment while potentially lessening rates of toxicity associated with continuous therapy strategies and at the same time lessen costs associated with ART
Detailed Description:
Long-term toxicity and the high cost of medications are two problems faced by HIV infected people taking ART Previous studies in HIV-infected patients suggest that ART with STIs may decrease drug exposure and lessen long-term drug toxicity while not sacrificing viral suppression and patient health This study will determine if ART with STIs can maintain the same level of immune function in HIV-infected people as continuous ART This study will recruit patients in South Africa
This study will last 35 years At study entry all participants will begin daily ART consisting of lamivudine lopinavirritonavir and stavudine At Month 6 only participants who have responded well to ART CD4 count greater than 450 cellsuL and viral load less than 50 copiesml at Month 6 will be randomly assigned to one of two groups Group 1 participants will participate in STIs during therapy and Group 2 participants will receive continuous therapy People in Group 1 will have treatment interruptions of 2 4 and 8 weeks of duration in between 16-week periods of ART Group 1 participants will re-initiate therapy if their CD4 count drops below 350 cells or evidence of clinical disease progression is present Group 2 participants will continue taking ART throughout the study
At screening participants will undergo medical history assessment a physical exam and magnetic resonance imaging MRI and dual energy x-ray absorptiometry DEXA scans There will be at least 22 study visits occurring approximately every 8 weeks each lasting 45 to 60 minutes At each study visit participants will be required to bring any remaining pills with them so adherence can be assessed and will undergo medical assessments Blood collection will occur at nearly all visits For female participants urine collection will occur at all visits Participants will receive rabies vaccinations at Weeks 16 17 and 22 A visit at Week 92 will include an MRI and participants will receive a rabies vaccine booster
This study will last 35 years At study entry all participants will begin daily ART consisting of lamivudine lopinavirritonavir and stavudine At Month 6 only participants who have responded well to ART CD4 count greater than 450 cellsuL and viral load less than 50 copiesml at Month 6 will be randomly assigned to one of two groups Group 1 participants will participate in STIs during therapy and Group 2 participants will receive continuous therapy People in Group 1 will have treatment interruptions of 2 4 and 8 weeks of duration in between 16-week periods of ART Group 1 participants will re-initiate therapy if their CD4 count drops below 350 cells or evidence of clinical disease progression is present Group 2 participants will continue taking ART throughout the study
At screening participants will undergo medical history assessment a physical exam and magnetic resonance imaging MRI and dual energy x-ray absorptiometry DEXA scans There will be at least 22 study visits occurring approximately every 8 weeks each lasting 45 to 60 minutes At each study visit participants will be required to bring any remaining pills with them so adherence can be assessed and will undergo medical assessments Blood collection will occur at nearly all visits For female participants urine collection will occur at all visits Participants will receive rabies vaccinations at Weeks 16 17 and 22 A visit at Week 92 will include an MRI and participants will receive a rabies vaccine booster
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 |
|---|---|---|---|
| R01AI051986 | NIH | None | None |
| Protocol 2411209 | None | None | None |
| 1R01AI051986-01A2 | NIH | None | None |
| R01 A151986-01 | US NIH GrantContract | None | httpsreporternihgovquickSearch1R01AI051986-01A2 |