B24
Conditions
Interventions
Group 1: Tenofovir (TDF) + Emtricitabin (FTC)
or
Abacavir (ABC) + Lamivudin (3TC)
plus one Not Nucleosidale Reverse Transkriptase Inhibitor (NNRTI) (Efavirenz (EFV) or Nevirapine (NVP) or Rilpiviri
Sponsors
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
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are: 1. Percent of patients with HIV-1 RNA 200 cp/mL (based on the DHHS definition of virological failure) or a viral rebound to >200 cp/mL combined with subsequent treatment modification. 3. CD4 cell change from baseline and absolute CD4 cell count at months 12 and 24 (involving ITT and AT analyses), particularly in late presenters (defined as per the European consensus CD4750 CD4/µl compared to patients with CD4 =350/µl and no history of AIDS-defining event 5. Costs and cost effectiveness of current first-line HIV-treatment strategies and HIV-care considering the covariables and methods of the DAGNAE K3A study Annotations: Efficacy analyses will be stratified according to: A) The use of the third antiretroviral agent (PI/r versus NNRTI versus INI) B) NRTI Backbone C) Baseline HIV-RNA categories (i.e. >100.000 cp/mL vs. <= 100.000 cp/ml) and D) Baseline CD4 categories (i.e. <200, 200-349, 350-499, =500/µl). For certain questions patients are splitted in late presenters (defined as per the European consensus CD4<350/µl and/or history of an AIDS-defining event) in comparison to patients with CD4 =350/µl and early/less advanced HIV-disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: 1. Percent with HIV-1 RNA <200 cp/mL at months 12 (ITT analysis) and 24 (As-treated (AT) analysis) 2. Percent <50 cp/mL at months 12 and 24 (involving ITT analysis (based on the above mentioned snapshot algorithm) and AT analysis) 3. Durability of first-line ART, treatment discontinuations and modifications 4. Clinical outcomes and cost of late presenters (defined as per the European consensus CD4<350 and/or history of an AIDS-defining event) in comparison to patients with early/less advanced HIV-disease 5. Weight, blood pressure, waist/hip-measurement, quality of life, depression and phyisical well-being at baseline, months 12 and 24 | — |
Countries
Germany
Contacts
Public ContactChristian Hoffmann
ICH Study Center
Outcome results
None listed