Immediate Versus Deferred Antiretroviral Therapy in HIV-infected Patients Presenting With Acute AIDS-defining Events (IDEAL-Study)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 61
- Locations
- 17
- Primary Endpoint
- Death, all new/relapsing opportunistic infections and other grade 4 clinical endpoints within 24 weeks after randomization
Study Overview
Brief Summary
The purpose of this study is to compare the early versus deferred initiation of antiretroviral combination therapy consisting of tenofovir, emtricitabine and atazanavir/ritonavir in treatment naive patients who present with an acute AIDS-defining illness, namely pneumocystis pneumonia (PCP) or toxoplasma gondii encephalitis (TE).
Detailed Description
Objectives:
To compare the early versus deferred initiation of antiretroviral combination therapy consisting of tenofovir, emtricitabine and atazanavir/ritonavir in treatment naive patients who present with an acute AIDS-defining illness, namely pneumocystis pneumonia (PCP) or toxoplasma gondii encephalitis (TE).
The primary objective of this study is as follows:
To compare the rates of clinical progression between both groups. Progression is defined as death, all new/relapsing opportunistic infections (OI), and other grade 4 clinical endpoints (evaluated by standardized toxicity tables) within 24 weeks after randomization.
The secondary objectives of this study are:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (at least 18 years) HIV-1 infected subjects
- •Antiretroviral naïve HIV-1-infected patients who have developed an acute AIDS defining event, namely PCP or Toxoplasmosis (women receiving prior MTCT prophylaxis may be enrolled)
- •Patients who are able to take or to receive antiretroviral treatment and who are able to give written consent
Exclusion Criteria
- •Renal failure or CrCl < 60 mL/min
- •Patients who are not able to initiate ART or with current contraindications against atazanavir/ritonavir
- •Other AIDS-defining events than PCP or TE (exceptions see below)
- •Pregnancy/Women of childbearing potential who want to become pregnant
Arms & Interventions
Immediate arm
Immediate arm: ART should be initiated as soon as possible but no later than 3 days after initiation of OI treatment.
Intervention: Time of starting antiretroviral therapy (Other)
Deferred arm
Deferred arm: ART should be initiated after the completion of OI treatment which is achieved at the earliest at day 21 for PCP and at day 28 for TE. ART should be initiated no later than 6 weeks after initiation of OI treatment.
Intervention: Time of starting antiretroviral therapy (Other)
Outcomes
Primary Outcomes
Death, all new/relapsing opportunistic infections and other grade 4 clinical endpoints within 24 weeks after randomization
Time Frame: 24 weeks
Clinical Progression (death, all new or relapsing OI, other Grade 4 clinical endpoint) within 24 weeks. For abnormalities not found in the Toxicity Tables, a Grade 4 event will be defined as potentially life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable). Patients who drop out of study observation before end of week 12 are counted as clinical progression.
Secondary Outcomes
- incidence of immune reconstitution inflammatory syndrome(24 weeks)
- Hospitalization days after completion of initial OI treatment between both groups(24 weeks)
- efficacy and toxicity of the antiretroviral therapy(24 weeks)
- virological outcome(24 weeks)
- quality of life(24 weeks)
- immunological outcome(24 weeks)