Immediate versus deferred anti-HIV-therapy in patients presenting acute AIDS-defining events.

• 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.; MedDRA version: 18.0Level: LLTClassification code 10001509Term: AIDSSystem Organ Class: 100000004862; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2010-022413-26-DE
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-20
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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.

•Malignancies requiring any systemic therapy within 30 days of baseline

•Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance

•Subjects currently taking part in any other clinical trial using an investigational product, with the exception of studies where the treatment studied has been stopped for more than 1 month prior to baseline

•Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified