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Klinische Studien

1. Rekrutierungphase läuft

PROPHET
Prospective clinical and pharmacoeconomic outcomes study of different first-line antiretroviral treatment strategies (Deutscher Titel: Prospektive klinische und pharmakoökonomische Beobachtungsstudie zu verschiedenen antiretroviralen Primärtherapien)

MSD MK-0518–292-00
A Phase III Multicenter, double-Blind, randomized, active Comparator-Controlled Clinical Trial to Evaluate the Saftey and Efficacy of Raltegravir (MK-0518) 1200mg Once Daily versus Raltegravir (MK-0518)400mg twice daily, each in Combination with Truvada, in Treatment –Naïve-HIV-1Subjects

2. Rekrutierungsphase beendet, Studie läuft

GSK 200056 Latte-2
A Phase IIb Study Evaluating a Long-Acting Intramuscular Regimen of GSK1265744 plus TMC278 For The Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral regimen of GSK1265744 plus Abacavir/Lamivudine in HIV-1 Infected, Antiretroviral Therapy-Naive Adult Subjects

GS-US-292-0109
A Phase 3, Open-Label Study to Evaluate Switching from a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects

GS-US-104-0423
Study Title: A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects

A4001067-Maraviroc POEM
An international, multi-center, prospective epidemiologic cohort study of the safety of maraviroc used with optimized background therapy in treatment experienced HIV-1 infected patients

GS-US-236-0121 STRATEGY
A Phase 3b Randomized, Open-Label Study to Evaluate Switching from Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/
Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients

NEW ERA STUDY – HIV and Eradication: A multicenter, open-label, non-randomized trial to valuate treatment with multi-drug class (MDC) HAART and its impact on the decay rate of latently infected CD4+ T cells.
The purpose of this study is to decrease viral reservoirs in N=40 HIV-infected patients with either primary infection or chronic infection and successful HAART for at least three years. All patients will be started on a multi drug HAART including two NRTI, one PI, a CCR5-inhibitor and an integrase inhibitor. Decay of viral reservoirs like latently HIV-infected CD4+ T-cells will be monitored over time.

3. Abgeschlossene Studien

Pfizer A4001095 MODERN
A multicenter, randomized, double-blind, Comparative Trial of Maraviroc + Darunavir/Ritonavir versus Emtricitabine /tenofovir + Darunavir/Ritonavir for Treatment of Antiretroviral- naïve HIV Infected Patients with CCR5-Tropic HIV-1

BI 1220.19
Safety and Efficacy of 240mg BI 201335 once daily in combination with pegylated interferon alpha 2a and ribavirin for treatment of chronic Hepatitis C (HCV) genotype 1 infection in HIV/HCV co- infected patients . A multinational, randomized, parallel group , open label trial

GS-US-264-0110
A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared with a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

GSK ING 114467 – SINGLE
A Phase 3, randomized, double-blind study of the safety and efficacy of GSK 1349572 plus abacavir/lamivudine fixed-dose combination therapy administered
Once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy naïve adult subjects

GSK ING 113086 – SPRING-2
A Phase 3, randomized, double-blind study of the safety and efficacy of GSK 1349572 50mg once daily to raltegravir 400mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral therapy naïve adult subjects

GS-US-236-0103 (‚Quad‘)
A Phase 3, Randomized;Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-Infected;Antiretroviral Treatment-Naïve Adults

GSK Th-HIV-010 112353 Impfstudie
This study will test the safety and immunogenicity of the gp120/NefTat/AS02A vaccine candidate in individuals with chronic HIV-1 infection successfully treated with HAART. The rationale for this study is based on previous scientific experiments, including data indicating that this vaccine can elicit strong HIV-1-specific T cell immune responses in humans and monkeys and lead to a retardation of HIV-1 disease progression in animal models of HIV-1 infection.

GSK 114083 (TH-HIV-011) Impfstudie
Long-term follow up of study participants from GlaxoSmithKline (GSK) Biologicals – sponsored clinical trials evaluating Human Immunodeficiency Virus vaccine (F4co(p24-RT-Nef-p17)/AS01B vaccine) (732462) for therapeutic use

Victor E4
Vicriviroc in combination treatment with an optimized ART regimen in HIV-infected treatment-experienced subjects.

MK 0518-071 QDMRK
A phase III multicenter, double blind, randomized, active comparator-controlled clinical trial to study the safety and efficacy of once daily Raltegravir versus twice daily Raltegravir, each in combination with Truvada in NAIVE PATIENTS

BI-Nr. 1100.1486 VERXVE
A randomised, double blind, double dummy, parallel group, active controlled trial to evaluate the antiviral efficacy of 400 mg QD Viramune extended release formulation in comparison to 200 mg BID Viramune immediate release in combination with Truvada® in antiretroviral therapy naïve HIV-1 infected patients

MK-0518, Prot. Nr. 018 BENCHMRK-1
A multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of MK0518 in combination with an optimized background therapy (OBT), versus optimized background therapy alone, in HIV-infected patients with documented resistance to at least 1 drug

TMC114-C211 ARTEMIS
A randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114/ritonavir versus lopinavir/ritonavir in treatment-naïve HIV-1 infected subjects.

A4001078 MVC
Pilot Study of novel combination of Maraviroc + ATV/r vs TVD + ATV/r for treatment naive HIV-Infected Patients with R5 HIV -1

GS-US-183-0145 –Elvitegravir
A multicenter, randomized, double-blind,double-dummy, phase 3 study of the safety and efficacy of ritonavir boosted Elvitegravir(EVG/r) versus Raltegravir(RAL) each administered with a background regime in HIV-Infected, antiretroviral treatment experienced adults

Assert CAN 109586
Study of Once-Daily Abacavir/Lamivudine versus Tenofovir/Emtricitabine, Administered with Efavirenz in Antiretroviral-Naïve, HIV-1 Infected Adult Subjects.

Monark, FRAN03-001
A pilot, open label, randomized, comparative study of the antiviral efficacy of Lopinavir/Ritonavir single-drug regimen versus Lopinavir/Ritonavir in combination with Lamivudine/Zidovudine in antiretroviral naive patients.

HIV-NEF-004
A single-blind, randomized, controlled, phase II study to evaluate immunogenicity and safety of two doses of the MVA-BN nef HIV vaccine in HIV-1 infected patients with CD4>250/µl (HIV-NEF-004).

3TC Mono Study
Prospective study of switch to 3TC monotherapy with evaluation of replication capacity in patients with virologic failure and 3TC resistance (a multicenter prospective clinical study with the SHCS)

TMC114-C215
An open label 48-week trial of TMC114/RTV in HIV-1 infected subjects who failed treatment in the control group of sponsor selected trials with TMC114.

TMC114-C208
An open label trial of TMC114/RTV in HIV-1 infected subjects who were randomised in the trials TMC114-C201 or TMC114-C207.

TMC125-C216 DUET 2
A Phase III randomized, double-blinded, placebo-controlled trial to investigate the efficacy, tolerability and safety of TMC125 as part of an ART including TMC114/RTV and an investigator-selected OBR in HIV-1 infected subjects with limited to no treatment options.

TMC125-C217
An open-label trial with TMC 125 as part of an ART including TMC114/rtv and an investigator-selected OBR in HIV-1 infected subjects who participated in a DUET trial (TMC125-C206 or TMC125-C216)

TMC125-C214
Early Access of TMC125 in combination with other antrietrovirals in treatment experienced HIV-1 infected subjects with limited treatment options.

SILCAAT
Multizentrische, randomisierte Phase-III-Studie zur Untersuchung der biologischen und klinischen Wirksamkeit von subkutan verabreichtem, rekombinanten humanen Interleukin-2 an HIV-infizierten Patienten mit niedrigen CD4+- Werten unter aktiver antiretroviraler Therapie.

HPR20001
A Phase IIB, randomized, multicenter, parallel group study to evaluate the short-term safety, pharmacokinetics and antiviral effect of four blinded dosing regimens of GW640385/Ritonavir therapy compared to open-label current PI therapy in HIV-1 infected, Protease Inhibitor experienced adults for 2 weeks with long-term evaluation (>48 weeks) of safety, pharmacokinetic and antiviral activity of selected GW640385/RTV dosing regimen(s) vs. a Ritonavir-boosted, Protease Inhibitor containing regimen.

BI-Nr. 1100.1452
A Case-Control Toxicogenomics Study to identify Unique Genetic Polymorphisms in Patients who have experienced Symptomatic Hepatotoxicity or Severe Cutaneous Toxicity within the First 8 weeks of Nevirapine Therapy.

CNA106030 (HSR/Predict)
A phase IV, randomised, multicentre, double-blind study to evaluate the clinical utility of prospective genetic screening (HLA-B+5701) for susceptibility to Abacavir hypersensitivity.

CONNECT ML20083
Einarmige prospektive nicht interventionelle Beobachtungsstudie zur Anwendung von Fuzeon.

MK-0518, Prot. Nr. 023
Early access of MK-0518 in Combination with an optimized background antiretroviral therapy (OBT) in highly treatment experienced HIV-1 infected patients with limited to no treatment.

MK-0518, Prot. Nr. 032
Sicherheit und antiretrovirale Wirksamkeit von MK-0518 gegenüber KALETRA bei HIV-infizierten Patienten nach Umstellung von einer stabilen Therapie auf der Grundlage von KALETRA.

A4001050
A multicenter, open label, expanded access trial of Maraviroc.

A phase II randomized, controlled, partially blinded, 48-week trial to investigate dose-response of TMC114/RTV in 3-class-experienced, multi PI-experienced HIV-1 infected subjects.

TMC114-C151
„The pharmacokinetic interaction between TMC114, lopinavir and ritonavir, in HIV-1 infected subjects “,unter der Prüfleitung von Herrn Priv.-Doz. Dr. Keikawus Arastéh, Epimed GmbH, Berlin

TPV-Studie 1182.68
An open label safety study of Tipranavir co-administered with low-dose Ritonavir (TPV/r) in patients with advanced HIV-1 infection and limited treatment options

TPV-Studie 1182.17
A long-term open-label rollover trial assessing the safety and tolerability of combination tipranavir and ritonavir use in HIV-1 infected subjects.

TPV-Studie
Studiennummer 1182.48 RESIST2
Randomized, open-label, comparative safety and efficacy study of tipranavir boosted with low dose ritonavir (TPV/RTV) versus genotypically-defined protease inhibitor/ritonavir (PI/RTV) in multiple antiretroviral drug-expirienced patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug ReSistant Patients with Tipranavir)

APV30005
An open-label phase III study to assess the long term safety profile of GW433908 containing regimens in HIV-1 infected subjects.

APV40003
Sicherheit und Wirksamkeit von GW433908 im Rahmen der antiretroviralen Kombinationstherapie bei HIV-infizierten Patienten

ABT – 378/r (ABT – 378/ritonavir) Early Access Program,
Protocol Number M99-046
Programm für die vorzeitige Anwendung von ABT 378/r

Serostim – Recombinant Human Growth Hormone, mammalian-cell derived
(r-hGH (m), somatropin) – A randomized, parallel group, double-blind, placebo-controlled, dose-ranging, multicenter study of recombinant human growth hormone in the treatment of HIV-associated catabolism / wasting

AI424-009: Untersuchung zur antiretroviralen Wirksamkeit von zwei verschiedenen Dosierungen eines neuen Hemmstoffes der HIV-1 Protease, BMS-232632, in Kombination mit Saquinavir und zwei neuen NRT‘s bei vorbehandelten Patienten mit Therapieversagen unter einer Dreifachkombination.

PRO30013: Offene Prüfung einer Amprenavir- Behandlung bei erwachsenen Patienten mit HIV-Infektion, bei denen eine Standardtherapie mit Protease-Inhibitoren versagt hat oder nicht vertragen wurde.

Studie AZL30002 TRIZAL

INITIO: Eine offene, randomisierte Studie zur Evaluierung von verschiedenen therapeutischen Strategien in der Kombinationstherapie zur Behandlung der HIV-1-Infektion

Studie GS-99-903:
A Phase 3, Randomized, Double-Blind, Multicenter Study of the Treatment of Antiretroviral Naïve, HIV-1 Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination with Lamivudine and Efavirenz Versus Stavudine, Lamivudine and Efavirenz

I424-900: Atazanavir (BMS-232632) for HIV Infectet individuals: An Early Access Programm

A Phase III, Randomized;Open Label,Parallel, Multiccenter Study to Evaluate Treatment with Fixed-Dose Combination of Abacavir/Lamivudine (600mg/300mg) Once daily versus Abacavir (300mg) Twice-Daily and Lamivudine (300mg) Once-Daily in Combination with Tenofovir Once-Daily and a new PI or NNRTI for 48 weeks in ART-Experienced HIV-1 Infected Patients.

R278474-C202
A phase II, proof of principle (POP), randomized, open label trial in HIV-1 infected subjects with NNRTI experience and/or genotypic evidence of NNRTI resistance, who will receive R278474 once daily for 7 days in substitution for the NNRTI or PI in failing ART.

T20-305/NV16391: A phase III open-label safety study of T-20/Ro 29-9800
(HIV-1 fusion inhibitor) in combination with oral antiretroviral, in patients who
are unable to construct a viable regime