Drug Interaction Study Between GSK1349572 and Tipranavir/Ritonavir in Healthy Volunteers

2014-08-27 03:15:54 | BioPortfolio


The purpose of this study is to determine whether there is a drug interaction between GSK1349572 and the HIV protease inhibitors Tipranavir/Ritonavir (TPV/RTV).


The construction of a new antiretroviral regimen with GSK1349572 in raltegravir-resistant subjects will likely require less commonly used agents such as tipranavir and enfuvirtide. Ritonavir-boosted tipranavir (TPV/RTV) has been shown to induce drug metabolizing enzymes and lead to decreased exposure of some antiretrovirals thus necessitating a drug interaction study with GSK1349572 as GSK1349572 is eliminated primarily by metabolism.

This is a single-center, single sequence, open-label, three-period study, in adult male and female healthy subjects. Approximately 18 subjects will receive GSK1349572 50mg QD for 5 days (Treatment A). Subjects will then be administered TPV/RTV 500/200mg BID for 7 days (Treatment B) followed by the combination of GSK1349572 50mg QD and TPV/RTV 500/200mg for 5 days (Treatment C). There will be no washout periods between treatments. Safety evaluations will be collected during each treatment period. Serial PK samples for GSK1349572 will be collected and compared between Treatment A and C. A follow-up visit will occur 7-14 days after the last dose of study drug.

The study will be conducted at one centre in the US with healthy adult male and female subjects.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Infection, Human Immunodeficiency Virus




GSK Investigational Site
United States





Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:54-0400

Clinical Trials [2219 Associated Clinical Trials listed on BioPortfolio]

GSK1349572 Relative Bioavailability Study

This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects. Part A will evaluate the relative bioavailability of two new tablet formulations compa...

A Clinical Research Study for Assessing the Effectiveness of the New Integrase Inhibitor GSK1349572 in HIV-infected Persons With Prior Antiretroviral Treatment and Resistance to Raltegravir

Integrase is an enzyme produced by HIV so that the virus can multiply in the human body. GSK1349572 is a new drug in the integrase inhibitor class that prevents the enzyme from working pro...

Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection

This phase II clinical trial studies the side effects of pomalidomide and how well it works in treating patients with Kaposi sarcoma and human immunodeficiency virus (HIV) infection. Biolo...

3BNC117 and 10-1074 in HIV Uninfected Adults

This is a phase 1 clinical trial to evaluate the safety and pharmacokinetics of the highly neutralizing anti-human immunodeficiency virus-1 monoclonal antibodies 3BNC117 and 10-1074, when ...

GSK1349572 First Time in Human Study

To determine safety, tolerability and pharmacokinetics of GSK1349572

PubMed Articles [17361 Associated PubMed Articles listed on BioPortfolio]

Risk Factors for Human Papillomavirus Infection and Abnormal Cervical Cytology Among Perinatally Human Immunodeficiency Virus-Infected and Uninfected Asian Youth.

Infection with high-risk human papillomavirus (HR-HPV) may be higher in perinatally human immunodeficiency virus (HIV)-infected (PHIV) than HIV-uninfected (HU) adolescents because of long-standing imm...

Erythrodermic psoriasis and human immunodeficiency virus: association and therapeutic challenges.

Erythrodermic psoriasis is a rare but severe type of psoriasis that may be triggered by human immunodeficiency virus infection. We describe the case of a 65-year-old male patient with chronic psoriasi...

A Small-Molecule CD4-mimetic Compound Protects BLT Humanized Mice from Human Immunodeficiency Virus Infection.

Small-molecule CD4-mimetic compounds (CD4mc) inhibit human immunodeficiency virus (HIV-1) entry by blocking binding to the CD4 receptor and by premature triggering of the viral envelope glycoprotein (...

Generic velpatasvir plus sofosbuvir for hepatitis C virus infection in patients with or without human immunodeficiency virus coinfection.

Data are limited regarding the effectiveness and safety of generic velpatasvir plus sofosbuvir (VEL/SOF) for hepatitis C virus (HCV) in patients with or without human immunodeficiency virus (HIV) coin...

Adherence to antiretroviral therapy and correlation with adverse effects and coinfections in people living with HIV/AIDS in the municipality of Goiás State.

Acquired immunodeficiency syndrome is an advanced stage of a human immunodeficiency virus infection. The antiretroviral therapy aims to improve the life quality of HIV patients and a good adherence is...

Medical and Biotech [MESH] Definitions

Proteins encoded by the REV GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

Proteins encoded by the TAT GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

Proteins encoded by the VPR GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

Proteins encoded by the VIF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

Proteins encoded by the NEF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

More From BioPortfolio on "Drug Interaction Study Between GSK1349572 and Tipranavir/Ritonavir in Healthy Volunteers"

Quick Search


Relevant Topics

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

AIDS; Acquired Immune Deficiency Syndrome. HIV; Human Immunodeficiency Virus HIV infection causes AIDS. HIV infection also causes the production of anti-HIV antibodies, which forms the test for HIV in patients. People who have the HIV antibodies are ...

Searches Linking to this Trial