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A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects

A Phase IIb Study to Select a Once Daily Dose of GSK1349572 Administered With Either Abacavir/Lamivudine or Tenofovir/Emtricitabine in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

NCT00951015•ViiV Healthcare

View on ClinicalTrials.gov

Summary

This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.

Detailed Description

This Phase IIb study in HIV-infected antiretroviral naive adult subjects will include a dose-ranging evaluation of GSK1349572 10mg, 25mg and 50mg once daily blinded doses and a control arm of open label efavirenz 600mg once daily. Background ART for all study subjects will be chosen by the investigators and will be either Truvada or Epzicom/Kivexa. Data from the three doses of GSK1349572 will be compared on the basis of antiviral activity, safety/tolerability and pharmacokinetics over 16-24 weeks. Several planned interim analyses will evaluate data in real time; any doses considered inferior will be dropped and subjects on those doses of GSK1349572 will have the option to switch to either the highest dose still under investigation or the selected dose. Subjects will be able to remain in the study, unless they reach a stopping criterion, for at least 96 weeks. ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•HIV-1 infected male or female adults at least 18 years of age. Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol);
•HIV-1 infection with a screening plasma HIV-1 RNA greater than or equal to 1000copies/mL;
•CD4+ cell count greater than or equal to 200cells/mm3 (or higher as local guidelines dictate);
•ART-naive (less than or equal to 10 days of prior therapy with any antiretroviral agent). Any previous exposure to an HIV integrase inhibitor other than GSK1349572 will be exclusionary.
•No evidence of viral resistance to any antiretroviral drug indicative of primary transmitted resistance at screening;
•Able to understand and comply with protocol requirements;
•Able to provide written informed consent prior to screening;
•French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
•Note: Subjects starting abacavir as part of the NRTI backbone must have been screened and be negative for the HLA-B\*5701 allele.

Exclusion Criteria

•Any pre-existing or serious mental or physical disorder which could compromise ability to comply with the protocol or compromise subject safety;
•Women who are pregnant or breastfeeding;
•An active AIDS-defining condition at the screening visit;
•Previous participation in an experimental drug and/or vaccine trial(s) within 30 days or 5 half-lives;
•History of clinically relevant pancreatitis or hepatitis within the previous 6 months, including HBsAg positive result. Asymptomatic HCV infection will not be exclusionary, however subject who will require HCV therapy during the trial should be excluded. Any subject with a history of liver cirrhosis with or without hepatitis viral co-infection will be excluded.
•Any condition which could interfere with the absorption, distribution, metabolism or excretion of the drug;
•Any acute or Grade 4 laboratory abnormality at screening;
•History of upper gastrointestinal bleed and/or subjects with active peptic ulcer disease;
•Estimated creatinine clearance \<50 mL/min;
•Alanine aminotransferase (ALT) greater than or equal to 5 times ULN;
+12 more criteria

Locations (35)

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Bakersfield, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

Key Dates

Start Date

July 30, 2009

Primary Completion Date

February 26, 2010

Completion Date

December 22, 2016

Last Updated

January 16, 2018

Enrollment

208

ACTUAL participants

Conditions

Infection, Human Immunodeficiency Virus

Interventions

GSK1349572

DRUG

efavirenz

DRUG

Phase Ib/IIa Clinical Study of ACC017 Tablets

NCT06719310

Infection, Human Immunodeficiency Virus

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COMPLETEDPHASE3

An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1)

NCT02831673

Infection, Human Immunodeficiency VirusHIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects

Inclusion Criteria

Exclusion Criteria

Phase Ib/IIa Clinical Study of ACC017 Tablets

An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1)

ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection

A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults

Open-label Study of Dolutegravir (DTG) or Efavirenz (EFV) for Human Immunodeficiency Virus (HIV) - Tuberculosis (TB) Co-infection

Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults