Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients

Completed · Phase 2

Conditions studied: HIV-1 Infection

In brief

This study was done to see if the combination of two anti-HIV medicines, dolutegravir (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, provide a safe, effective, and well-tolerated treatment for HIV. DTG is a type of HIV medicine called an integrase inhibitor; 3TC is a type of HIV medicine called a reverse transcriptase inhibitor. DTG works by blocking integrase and 3TC works by blocking reverse transcriptase, two HIV proteins (enzymes). This prevents HIV from multiplying and lowers the viral load (amount of HIV in the blood). Both DTG and 3TC are currently part of Food and Drug Administration (FDA) recommended regimens along with a third active drug. Since some HIV medicines have side effects and are costly, there is interest in whether HIV can be successfully controlled with fewer than three HIV drugs.

Key facts

Study ID

NCT02582684

Run by

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

People needed

122

Starts

2015-12-08

Expected to finish

2017-09-26

Last updated by the study team

2018-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infection.
• Plasma HIV-1 RNA ≥1000 copies/mL and <500,000 copies/mL obtained within 90 days prior to study entry.
• No evidence of any RT, any integrase, or major protease resistance mutation (according to the 2014 IAS-USA drug resistance mutations list, available at https://www.iasusa.org/sites/default/files/tam/22-3-642.pdf) based on pre-ARV (antiretroviral) treatment genotype performed any time prior to study entry.
• ARV treatment drug-naive (defined as no previous ARV treatment at any time prior to study entry, with the exception of successful post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP).
• The following laboratory values obtained within 45 days prior to study entry:
• ANC (absolute neutrophil count) ≥750/mm\^3
• Hemoglobin ≥10.0 g/dL
• Platelets ≥ 50,000/mm\^3
• Calculated creatinine clearance (CrCl) ≥50 mL/min, as estimated by the Cockcroft-Gault equation
• AST (aspartate aminotransferase) <5 x ULN (upper limit of normal)
• ALT (alanine aminotransferase) <5x ULN
• Total bilirubin <1.5 x ULN
• Hepatitis B surface antigen negative within 45 days prior to study entry.
• For women with reproductive potential, negative serum or urine pregnancy test at screening and within 48 hours prior to study entry.
• If participating in sexual activity that could lead to pregnancy, female participants with reproductive potential must have agreed to use one form of contraceptive as listed in the protocol while receiving protocol-specified medications and for 30 days after stopping the medications.
• Ability and willingness of participant or legal representative to provide informed consent.

You may not qualify if…

• Serious illness requiring systemic treatment and/or hospitalization.
• Treatment within 30 days prior to study entry with immune modulators such as systemic steroids, interleukins, interferons, granulocyte colony-stimulating factor (G-CSF), erythropoietin, or any investigational therapy.
• Pregnancy or breastfeeding.
• Receipt of systemic cytotoxic chemotherapy or dofetilide.
• Known allergy/sensitivity to any of the study drugs or their formulations.
• Active drug or alcohol use or dependence that may interfere with adherence to study requirements, in the opinion of the site investigator.
• Active hepatitis C virus (HCV) treatment or anticipated need for treatment within study period.
• Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• Severe hepatic impairment (Class C) as determined by Child-Pugh classification.

Where it is running

• University of Southern California CRS (1201) — Los Angeles, California, United States
• UCLA CARE Center CRS (601) — Los Angeles, California, United States
• Ucsd, Avrc Crs (701) — San Diego, California, United States
• Harbor-UCLA Med. Ctr. CRS (603) — Torrance, California, United States
• University of Colorado Hospital CRS (6101) — Aurora, Colorado, United States
• Univ. of Miami AIDS CRS (901) — Miami, Florida, United States
• The Ponce de Leon Center CRS (5802) — Atlanta, Georgia, United States
• Northwestern University CRS (2701) — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS (2702) — Chicago, Illinois, United States
• Massachusetts General Hospital ACTG CRS (101) — Boston, Massachusetts, United States
• Brigham and Women's Hosp. ACTG CRS (107) — Boston, Massachusetts, United States
• Washington University CRS (2101) — St Louis, Missouri, United States
• Cornell CRS (7804) — New York, New York, United States
• Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea (7803) — New York, New York, United States
• Columbia Physicians and Surgeons CRS (30329) — New York, New York, United States
• University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787) — Rochester, New York, United States
• 3201 Chapel Hill CRS — Chapel Hill, North Carolina, United States
• Greensboro CRS (3203) — Greensboro, North Carolina, United States
• Univ. of Cincinnati CRS (2401) — Cincinnati, Ohio, United States
• The Ohio State Univ. AIDS CRS (2301) — Columbus, Ohio, United States
• Hosp. of the Univ. of Pennsylvania CRS (6201) — Philadelphia, Pennsylvania, United States
• The Miriam Hospital ACTG CRS (2951) — Providence, Rhode Island, United States
• Vanderbilt Therapeutics CRS (3652) — Nashville, Tennessee, United States
• 31443 Trinity Health and Wellness Center CRS — Dallas, Texas, United States
• Houston AIDS Research Team CRS (31473) — Houston, Texas, United States

Full record on ClinicalTrials.gov

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