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Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Lamivudine in HIV-1-Infected Adults Who Are Virologically Suppressed
 
Region Sponsors
California - Northern
GlaxoSmithKline
ViiV Healthcare, Inc.
 
Acronym KP IRB No.
CN-18-3151
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
HIV-1 infected men or women.
 
Purpose
This will be a 100-week, Phase III, randomized, open-label, active-controlled, multicenter, parallel-group study. The study will include a screening phase (up to 28 days), a randomized early switch phase (Day 1 up to Week 52), a randomized late switch phase (Week 52 up to Week 100), and a continuation phase (post Week 100). Approximately 550 HIV-1 infected adults on stable TBR will be randomized 1:1 to switch to DTG + 3TC once daily for up to 100 weeks, or to continue their TBR for 52 weeks, at which time and if HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL) at Week 48, these participants will switch to DTG + 3TC up to Week 100.
 
Detailed Description
The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected adult participants with current virologic suppression on a =3-drug tenofovir alafenamide (TAF) based regimen (TBR) remain suppressed upon switching to a two-drug regimen of dolutegravir (DTG) 50 milligram (mg) + lamivudine (3TC) 300 mg. This study will also provide important information regarding the safety and participant satisfaction with this two-drug regimen. The primary objective of this trial is to demonstrate the non-inferior antiviral activity of switching to DTG + 3TC once daily compared to continuation of TBR over 48 weeks in HIV-1 infected, ART-experienced, virologically suppressed participants. This study also will characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC through Week 100.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Participant must be able to understand and comply with protocol requirements, instructions, and restrictions.
  • Participant must be likely to complete the study as planned.
  • Participant must be considered an appropriate candidate for participation in an investigative clinical trial with medication (e.g. no active substance abuse, acute major organ disease, or planned long-term work assignments out of the country).
  • Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening.
  • Plasma HIV-1 RNA <50 c/mL at Screening.
  • Must be on uninterrupted ART for at least 6 months prior to screening.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions of the consent form and the protocol. Eligible participants or their legal guardians must sign a written informed consent form before any protocol-specified assessments are conducted.
  • Please contact study team for more eligibility criteria.
 
Exclusion Criteria
  • Women who are breastfeeding or plan to become pregnant or breastfeed during the study.
  • Any evidence of an active CDC Stage 3 disease, EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy.
  • Participants with severe hepatic impairment (Class C).
  • Unstable liver disease, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Anticipated need for any HCV therapy during the first 48 weeks of the study, for HCV therapy based on interferon or for any drugs that have a potential for adverse drug-drug interactions with study treatment.
  • Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.
  • 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 systemic immune suppressant.
  • 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, prior to the first dose of investigational product.
  • Use of any regimen consisting of single or dual ART.
  • Any verified Grade 4 laboratory abnormality.
  • Alanine aminotransferase (ALT) >/=5 times the upper limit of normal (ULN) or ALT >/=3 times ULN and bilirubin >/= 1.5 times ULN (with >35% direct bilirubin).
  • Creatinine clearance of <50 mL/minute/1.73 meter^2 via CKD-EPI method.
  • Please contact study team for more eligibility criteria.

 
Keywords and/or Specific Medical Conditions
  • Immunologic Deficiency Syndromes
  • Lamivudine
  • Acquired Immunodeficiency Syndrome
  • Lentivirus Infections
  • Anti-HIV Agents
  • Molecular Mechanisms of Pharmacological Action
  • Anti-Infective Agents
  • non-inferiority
  • Anti-Retroviral Agents
  • Nucleic Acid Synthesis Inhibitors
  • Antiviral Agents
  • Retroviridae Infections
  • Dolutegravir
  • Reverse Transcriptase Inhibitors
  • dolutegravir plus lamivudine
  • RNA Virus Infections
  • Enzyme Inhibitors
  • Sexually Transmitted Diseases
  • HIV Infections
  • Sexually Transmitted Diseases, Viral
  • HIV Integrase Inhibitors
  • Slow Virus Diseases
  • HIV-1
  • tenofovir alafenamide
  • Immune System Diseases
  • Virus Diseases
  • Integrase Inhibitors
  • Switch study
 
KP Clinical Facility
  • Hayward Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
 
Clinical Area


Principal Investigator:
Jason Flamm, MD
Contact Information:
- Catherine Vowles
-Catherine.Vowles@kp.org
-San Francisco Medical Center


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