A Phase IIb pilot study to assess the antiviral activity of GSK1349572 containing regimen in antiretroviral therapy (ART)-experienced, HIV-1-infected adult subjects with raltegravir resistance - VIKING

Phase 1

• Conditions: HIV-1 infected antiretroviral therapy experienced adults with raltegravir resistance; MedDRA version: 9.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV

• Registration Number: EUCTR2009-010270-37-FR
• Lead Sponsor: GlaxoSmithKline Research and Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-07
• Study Completion: 2015-01-23
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 51

Inclusion Criteria

1. Subject has documented HIV-1 infection with a plasma HIV-1 RNA > 1,000 copies/mL at Screening.
2. Subject is ART-experienced (defined as on stable ART for at least the last 2 months) and is either currently experiencing virologic failure to RAL or experienced virologic failure to RAL >8 weeks prior to Screening (with documented genotypic and/or phenotypic RAL resistance at time of failure) and is currently experiencing treatment failure on a subsequent regimen
3. Subject has documented RAL genotypic resistance on Screening genotype
4. Subject has documented genotypic or phenotypic resistance to at least one drug from each of three or more of all approved classes of ART based on Screening genotype/phenotype and/or historical genotype/phenotype data.
5. Subject is >18 years of age. A female is eligible to enter and participate in the study if she falls into one of the following categories:
a. Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal defined as 24 months of spontaneous amenorrhea;
or,
b. Child-bearing potential, with a negative pregnancy test at screen and a negative pregnancy test at Day 1, who agrees to use one of the methods of contraception listed below. Premenarchal females who develop child-bearing potential while on study will be expected to follow one of the methods of contraception listed below.
• Complete abstinence from intercourse from 2 weeks prior to administration of the investigational products, throughout the study, and for at least 2 weeks after discontinuation of all study medications
• Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide).
• Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year
• Any other method with published data showing that the lowest expected failure rate for that method is less than 1% per year.
6. Subject or the subject’s legal representative is willing and able to understand and provide signed and dated written informed consent prior to screening.
7. 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any pre-existing mental, physical, or substance abuse disorder which, in the opinion of the investigator, may interfere with the subject’s ability to comply with the dosing schedule and/or protocol evaluations (including alcohol or drug abuse) or which may compromise the safety of the subject.
2. Pregnant women and women who are breastfeeding.
3. Any evidence of an active Centres for Disease Control and Prevention Category C disease except cutaneous Kaposi’s sarcoma not requiring systemic therapy at the Screening visit. Subjects may be enrolled provided they are on a stable, anti-infective treatment or prophylaxis regimen and are clinically improving at the Baseline visit.
4. Current use and/or anticipated need for EFV, NVP, FPV/RTV or TPV/RTV during the Functional Monotherapy or Combination Phases of the study.
5. Subjects who require treatment with any of the following medications within 15 days of commencement of investigational product, or anticipated need during the study: Etravirine (unless co-administered with LPV/RTV or DRV/RTV), rifampin, rifabutin, phenytoin, pheonobarbital, barbiturates, glucocorticoids, modafinil, oxcarbazepine, pioglitazone, troglitazone, carbamazepine, St. Johns wort.
6. Previous participation in an experimental drug and/or vaccine trials (s) as defined in the protocol, prior to the first dose of study medication.
7. History of ongoing or clinically relevant pancreatitis or hepatitis within the previous 6 months. Asymptomatic individuals with chronic hepatitis B and hepatitis C virus (HBV, HCV) infection will not be excluded, but should be carefully assessed if therapy specific for HCV infection is required; subjects who are anticipated to require such therapy during the first 24 weeks of the study should be excluded. Any subjects with evidence of cirrhosis with or without hepatitis viral co-infection should be excluded.
8. History of upper gastrointestinal bleed (unless in the opinion of the Investigator and Sponsor the primary cause was reversible and has been adequately treated) and/or subjects with active peptic ulcer disease
9. Screening haemoglobin <10g/dL (100g/L).
10. Subject suffers from a serious medical condition which in the opinion of the Investigator would compromise the safety of the subject.
11. Any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug or render the subject unable to take oral medication.
12. Screening lipase > 3 x upper limit of normal (ULN)
13. Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the subject’s participation in the study of an investigational compound. Any verified Grade 4 laboratory abnormality at Screening would exclude a subject from study participation unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the Sponsor.
14. Screening alanine aminotransferase (ALT) >5 x ULN. Subjects with ALT > 2xULN but <5xULN may participate in the study, if in the opinion of the Investigator and Sponsor the lab abnormality will not interfere with the study procedures or compromise subject safety.
15. Screening ALT >3xULN and bilirubin >

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified