Clinical Trials Logo
  1. Home
  2. HIV
  3. NCT01225705

Safety Study of Raltegravir in HIV/HCV Co-infected Patients

HIV Clinical Trial

Official title:
An Open, Prospective Study to Compare the Safety and Efficacy of Raltegravir vs. Atazanavir / Ritonavir, Both in Combination With Tenofovir DF and Emtricitabine, in the Treatment of HIV-infection in ART Naive Subjects With HCV Co-infection.

Clinical Trial Summary

Current European AIDS Clinical Society (EACS) guidelines for the treatment of HIV infection recommend a combination antiretroviral regimen composed of two nucleoside reverse transcriptase inhibitors plus a ritonavir boosted protease inhibitor or a non-nucleoside reverse transcriptase inhibitor.

The non-nucleoside reverse transcriptase inhibitors licensed for naïve patients - nevirapine and efavirenz - have both been asociated with increased rates of hepatotoxicity (nevirapine) and CNS toxicity (efavirenz) in HIV/HCV co-infected patients. Although PI-based therapy has dramatically reduced morbidity and mortality, it has been limited by complex dosing regimens and toxicities, leading to adherence challenges. Varying degree of liver insufficiency may necessitate pharmacokinetic monitoring of the protease inhibitor and may necessitate dose adjustments. In HIV/HCV co-infected patients HAART based on another class of antiretrovirals than NNRTI or PI may thus offer advantages with regard to adverse events and thus long-term efficacy.

The overall intention of this trial is to examine in a non-inferiority design the safety and efficacy of a raltegravir based HAART with a standard-of-care HAART in HIV-/HCV co-infected patients. The standard of care used in this study will be atazanavir/ritonavir. All patients will in addition receive a fixed combination of tenofovir and emtricitabine.

The primary end-point is the rate of hepatotoxic events, defined by ALT elevations.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01225705
Study type Interventional
Source University Hospital, Bonn
Contact
Status Withdrawn
Phase Phase 4
Start date October 2010
Completion date August 2012
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06162897 - Case Management Dyad N/A
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT02528773 - Efficacy of ART to Interrupt HIV Transmission Networks
Active, not recruiting NCT05454839 - Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Recruiting NCT05322629 - Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women N/A
Completed NCT02579135 - Reducing HIV Risk Among Adolescents: Evaluating Project HEART N/A
Active, not recruiting NCT01790373 - Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence N/A
Not yet recruiting NCT06044792 - The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
Completed NCT04039217 - Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM Phase 4
Active, not recruiting NCT04519970 - Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK) N/A
Completed NCT04124536 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women N/A
Recruiting NCT05599581 - Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health N/A
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Completed NCT02758093 - Speed of Processing Training in Adults With HIV N/A
Completed NCT02500446 - Dolutegravir Impact on Residual Replication Phase 4
Completed NCT03805451 - Life Steps for PrEP for Youth N/A
Active, not recruiting NCT03902431 - Translating the ABCS Into HIV Care N/A
Completed NCT00729391 - Women-Focused HIV Prevention in the Western Cape Phase 2/Phase 3
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2