HIV Infections Clinical Trial
Official title:
Randomized Study to Evaluate Immediate Potent Antiretroviral Therapy for HIV-Infected Subjects With CD4 Cell Counts Less Than 350 Cells/mm3 Admitted to Intensive Care Areas With an AIDS-Defining Illness, Pneumonia, or Sepsis
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.
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 3TC/ZDV, 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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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