Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055120
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2003-02-19
Brief Title:
When to Start Anti-HIV Drugs in Patients With Opportunistic Infections
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase IV Study of Antiretroviral Therapy for HIV Infected Adults Presenting With Acute Opportunistic Infections Immediate Versus Deferred Initiation of Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2014-10
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:
The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections OIs This study will follow two patient groups those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI
Detailed Description:
Despite the advent of highly active antiretroviral therapy HAART many HIV infected patients without access to antiretroviral therapy ART present with acute OIs Such presentations pose a management problem as there are currently no data available as to whether initiating HAART during the acute presentation is of benefit Reports of an immune reconstitution inflammatory syndrome IRIS marked by increasing hypoxia or new pulmonary infiltrates have been associated with the initiation of ART in patients with AIDS There is also concern as to drug interactions between ART and antimicrobials used to treat the presenting OI This study will evaluate the possible benefits and costs of initiating ART in HIV infected patients who present with an AIDS-defining OI
There are 2 steps in this study In Step 1 patients will be randomly assigned to one of two study arms Arm A will receive ART within 2 weeks of starting therapy for the acute OI Arm B will have ART deferred until Step 2 at least 4 weeks and no more than 32 weeks after beginning therapy for the acute OI Only Arm B participants will enter Step 2 which will likely begin between Weeks 6 and 12 The study will make the following drugs available for construction of an antiretroviral ARV regimen emtricitabinetenofovir disoproxil fumarate FTCTDF lopinavirritonavir LPVRTV and stavudine d4T Use of other ARV drugs is at the discretion of the study official Drug regimen additions and substitutions will be made on a case-by-case basis
Patients will be followed for 48 weeks and will have 10 study visits All study visits will include a physical exam medication history and blood collection Patients will be asked to complete questionnaires assessing health status and adherence at selected visits
There are 2 steps in this study In Step 1 patients will be randomly assigned to one of two study arms Arm A will receive ART within 2 weeks of starting therapy for the acute OI Arm B will have ART deferred until Step 2 at least 4 weeks and no more than 32 weeks after beginning therapy for the acute OI Only Arm B participants will enter Step 2 which will likely begin between Weeks 6 and 12 The study will make the following drugs available for construction of an antiretroviral ARV regimen emtricitabinetenofovir disoproxil fumarate FTCTDF lopinavirritonavir LPVRTV and stavudine d4T Use of other ARV drugs is at the discretion of the study official Drug regimen additions and substitutions will be made on a case-by-case basis
Patients will be followed for 48 weeks and will have 10 study visits All study visits will include a physical exam medication history and blood collection Patients will be asked to complete questionnaires assessing health status and adherence at selected 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 |
|---|---|---|---|
| DAIDS-ES ID 10005 | None | None | None |