PROPHET: Prospective clinical and pharmacoeconomic outcomes study of different first-line antiretroviral treatment strategies

• Conditions: B24; Unspecified human immunodeficiency virus [HIV] disease

• Registration Number: DRKS00006321
• Lead Sponsor: DAGNÄ e.V. (Deutsche Arbeitsgemeinschaft niedergelassener Ärzte in der Versorgung HIV-Infizierter e.V.) vertreten durch Dr. med. Knud Schewe und Dr. med. Stefan Klauke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-23
• Study Completion: 2017-11-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 444

Inclusion Criteria

1. The patient´s age at the date of inclusion is >18 years
2. Chronic HIV-infection, to date without HIV-treatment and indication of therapy start
3. Signed patient informed consent
4. Planned treatment initiation with backbone consiting of TDF+FTC or ABC+3TC in combination with a third antiretroviral drug
5. The third substance is either a Non-nucleosidale-Reverse-Transcriptase-Inhibitor NNRTI: (Efavirenz, Nevirapin, Rilpivirin), a boosted Protease-Inhibitor (PI/r: Darunavir/r, Lopinavir/r, Atazanavir/r, Fosamprenavir/r) or Integrase-Inhibitor (INI: Raltegravir, Elvitegravir/c, Dolutegravir).

Exclusion Criteria

1. Initiation of antiretroviral therapy which is not based on a backbone of TDF+FTC or ABC/3TC in combination with a NNRTI, PI/r or INI.
2. Acute HIV-infection, seroconversion
3. Prior use of antiretroviral drugs (a short-term therapy within the scope of a mother-to-child-transmission-prophylaxis is allowed)

Study & Design

• Study Type: observational
• Study Design: Not specified