Status:
COMPLETED
A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in the Central Nervous System in HIV-1 Infected ART-naive Subjects
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
Shionogi
GlaxoSmithKline
Conditions:
Infection, Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
ING116070 is a Phase IIIb single-arm, open-label, multicenter study. The study will be conducted in approximately 14 HIV-1 infected antiretroviral therapy (ART)-naïve subjects. Subjects who fulfill el...
Detailed Description
ING116070 is a Phase IIIb single-arm, open-label, multicenter study. The study will be conducted in approximately 14 HIV-1 infected antiretroviral therapy (ART)-naïve subjects. Subjects who meet all s...
Eligibility Criteria
Inclusion
- HIV-1 infected adults at least 18 years of age. Females are eligible to enter and participate in the study if she is (1) of non-childbearing potential or (2) of childbearing potential with a negative pregnancy test at Screening and Day 1 and agrees to use protocol-defined methods of birthcontrol while on the study.
- HIV-1 infection as documented by Screening plasma HIV-1 RNA greater than or equal to 5000 copies/mL
- CD4+ cell count greater than or equal to 200 cells/mm3
- Antiretroviral-naive (less than or equal to 10 days of prior therapy with any antiretroviral agent following diagnosis of HIV-1 infection)
- Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening
- Documentation that the subject has been screened for, and is negative for the HLA-B\*5701 allele
- Is willing to undergo serial lumbar punctures
Exclusion
- Relative or absolute contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets less than 50,000/microliter), hemophilia, or use of anticoagulant medication
- Moderate or severe cognitive impairment
- Women who are pregnant or breastfeeding
- Any evidence of an active Center for Disease Control and Prevention (CDC) Category C disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy or historic CD4+ cell levels less than 200cells/mm3
- Subjects with any degree of hepatic impairment
- Positive for Hepatitis B at screening (+HbsAg), or an anticipated need for Hepatitis C virus (HCV) therapy during the study
- History or presence of allergy or intolerance to the study drugs or their components or drugs of their class
- History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject
- Recent history (less than or equal to 3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
- Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any immunomodulators that alter immune responses
- Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 in vitro within 28 days of first dose of IP
- Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP
- Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result. Note: retests of Screening genotypes are not allowed
- Any verified Grade 4 laboratory abnormality (a single repeat test is allowed during the Screening period to verify a result). 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 is exclusionary
- Alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (ULN)
- ALT greater than or equal to 3xULN and bilirubin greater than or equal to 1.5xULN (with greater than 35% direct bilirubin)
- Subject has creatinine clearance of less than 50 mL/min via Cockroft-Gault method
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01499199
Start Date
January 1 2012
End Date
May 1 2014
Last Update
February 25 2015
Active Locations (3)
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1
GSK Investigational Site
Los Angeles, California, United States, 90069
2
GSK Investigational Site
San Diego, California, United States, 92103
3
GSK Investigational Site
Providence, Rhode Island, United States, 02906