Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028327
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
2001-12-20
Brief Title:
Potent Antiviral Therapy for Critically Ill HIV Infected Patients Admitted to Intensive Care
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Randomized Study to Evaluate Immediate Potent Antiretroviral Therapy for HIV-Infected Subjects With CD4 Cell Counts Less Than 350 Cellsmm3 Admitted to Intensive Care Areas With an AIDS-Defining Illness Pneumonia or Sepsis
Status:
COMPLETED
Status Verified Date:
2004-07
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:
Many HIV infected patients admitted to the intensive care area ICA have never taken anti-HIV drugs The purpose of this study is to learn whether starting anti-HIV drugs while patients are in an ICA will help them to survive and get better faster This study will also evaluate patients who though not in an ICA have been admitted to the hospital for serious illnesses or infections
Detailed Description:
There has been considerable debate over the management of HIV infected individuals admitted to the ICA Mortality in HIV infected patients in the ICA correlates with the level of immune suppression The majority of HIV infected individuals entering the ICA are antiretroviral naive Despite the high mortality rates and the opportunity to intervene with antiretroviral therapy physicians do not routinely administer highly active antiretroviral therapy HAART in the ICA Early initiation of HAART which improves immune function could potentially reduce mortality Numerous studies have shown that there is a dramatic drop in the HIV-1 RNA levels accompanied by an increase in the CD4 cell count within the first 2 to 4 weeks of therapy Sufficient data now exist that antiretrovirals could be administered in the ICA with careful monitoring and attention to drug interactions This study will evaluate the effect of HAART in patients admitted to the hospital with an AIDS-defining illness pneumonia or sepsis
Upon entry into the study patients are stratified according to a severity of illness score SAPS I and CD4 cell count Patients then are assigned to 1 of 2 study arms Arm A HAART lamivudine 3TC and zidovudine ZDV or 3TCZDV and nelfinavir NFV and efavirenz EFV or an alternative HAART for 4 weeks Arm B No antiretroviral regimen Evaluations of the following are performed drug toxicity immune status viral load arterial blood gas ventilator parameters and evolution of the presenting illness Pharmacokinetic trough concentration analyses are performed on all patients in Arm A during 3 time points of their illness Patients are followed for 24 weeks after entry Patients in Arm A may elect to participate in two substudies The first substudy will measure efavirenz and nelfinavir drug levels in the blood to determine how critical illness affects pharmacokinetics The second substudy will evaluate the benefit of HAART in HIV infected patients being treated for pneumocystis carinii pneumonia
Upon entry into the study patients are stratified according to a severity of illness score SAPS I and CD4 cell count Patients then are assigned to 1 of 2 study arms Arm A HAART lamivudine 3TC and zidovudine ZDV or 3TCZDV and nelfinavir NFV and efavirenz EFV or an alternative HAART for 4 weeks Arm B No antiretroviral regimen Evaluations of the following are performed drug toxicity immune status viral load arterial blood gas ventilator parameters and evolution of the presenting illness Pharmacokinetic trough concentration analyses are performed on all patients in Arm A during 3 time points of their illness Patients are followed for 24 weeks after entry Patients in Arm A may elect to participate in two substudies The first substudy will measure efavirenz and nelfinavir drug levels in the blood to determine how critical illness affects pharmacokinetics The second substudy will evaluate the benefit of HAART in HIV infected patients being treated for pneumocystis carinii pneumonia
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 |
|---|---|---|---|
| A5162s | None | None | None |
| AACTG A5141 | None | None | None |
| A5161s | None | None | None |