Immediate versus deferred antiretroviral therapy in HIV-infected patients presenting with acute AIDS-defining events (IDEAL-Study)

niversity Medical Center Hamburg-Eppendorf0 sitesApril 20, 2011

ConditionsPatients in late stage of HIV-infection, treatment naive or without ART for the last 6 month with an acute AIDS-defining illness, namely PCP or TE.MedDRA version: 18.0Level: LLTClassification code 10001509Term: AIDSSystem Organ Class: 100000004862 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

DrugsReyataz® 300mg-Hartkapseln Norvir® 100mg-Filmtabletten

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients in late stage of HIV-infection, treatment naive or without ART for the last 6 month with an acute AIDS-defining illness, namely PCP or TE.
Sponsor: niversity Medical Center Hamburg-Eppendorf
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 20, 2011

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Medical Center Hamburg-Eppendorf

Eligibility Criteria

Inclusion Criteria

•No prior antiretroviral therapy for at least 6 month and an acute AIDS defining event, namely PCP or TE.
•Naïve to antiretroviral therapy. No prior antiretroviral therapy for at least 6 month (patients without evidence for prior virological failure and without evidence of resistance mutation against the planned ART therapy may be allowed)and an and an
•Acute AIDS defining event, namely PCP or TE. Prior ART for mother to child transmission (MTCT) prophylaxis is allowed.
•Ability to take oral medications
•\>\= 18 years old
•Adequate renal function by calculated creatinine clearance \< 60 mL/min according to the Cockcroft–Gault formula.
•Negative serum pregnancy test (females of childbearing potential only i.e., not surgically sterile or at least 2 years post\-menopausal).
•Women of childbearing potential (WOCBP) must be using a highly effective method of contraception to avoid pregnancy throughout the study and for up to 30 days after the last dose of study drugs in such a manner that the risk of pregnancy is minimized – refer to Section x for the definition of highly effective method of birth control.
•Male subjects who are heterosexually active must be willing to use effective barrier contraception (e.g. condom with spermicide) from screening through completion of the study and continuing for up to 30 days after the last dose of study drugs
•The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. In the case the patient is not able to give informed consent his legal representative has to give informed consent for the patient. This can be done after the incompetence of given consent was confirmed by a psychiatric specialist.

Exclusion Criteria

•Pregnant or lactating subjects
•Prior antiretroviral treatment for the last six month
•Known hypersensitivity to atazanavir/ritonavir
•Documented resistance to any of the study drugs (either genotypic or phenotypic)
•Severe hepatic impairment
•Hepatic transaminases (aspartate aminotransferase \[AST] and alanine aminotransferase \[ALT]) \>/\= 5 x upper limit of normal (ULN)
•Subjects receiving ongoing therapy with any of the medications that are contraindicated with any of the study drugs. Administration of any of these medications must be discontinued at least 14 days prior to the Baseline visit and for the duration of the study period. The full list of disallowed medications can be found in Appendix IV.
•Other AIDS\-defining events (see Appendix VIII for definition of AIDS\-defining events) than PCP or TE present at screening, except for oesophageal candidiasis and Kaposi sarcoma (KS) not requiring systemic chemotherapy.
•Prior history of significant renal disease
•Any current known clinical or symptomatic laboratory parameter of Grade 4 (see Appendix ). Asymptomatic Grade 4 abnormalities will be permitted at the discretion of the investigator if deemed clinically appropriate (excluding adverse events and laboratory parameters mentioned elsewhere in the inclusion/exclusion criteria). Abnormalities deemed insignificant by the investigator must be discussed with the Medical Monitor prior to enrollment.