Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients
Condition: HIV-1 Infection
Intervention: Dolutegravir; Lamivudine
Intervention description: Participants were prescribed 50 mg of DTG orally daily; Participants were prescribed 300 mg of 3TC orally daily.
Intervention MeSH terms: Lamivudine; Dolutegravir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        NOTE: Further information on the eligibility criteria can be found in the study protocol.

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.