Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3

Inclusion Criteria:

1. Subject has voluntarily signed and dated an informed consent form, approved by anInstitutional Review Board (IRB) / Independent Ethics Committee (IEC), after thenature of the study has been explained and the subject has had the opportunity toask questions.

2. Documented HIV-1 infection defined as a positive rapid test or ELISA plus a plasmaHIV-1 RNA (>1,000 copies/mL) or a positive western blot. A previous result performedon the last 30 days can be used.

3. ≥18 years of age

4. Naïve to ARV therapies (defined as ≤ 10 days of prior therapy with anyantiretroviral therapy following an HIV diagnosis). Previous use of PrEP or PEP isallowed if there is documented HIV seronegativity between the last prophylactic doseand the date of HIV diagnosis.

5. HIV RNA at screening visit > or = 1,000 copies/mL. A previous result performed onthe last 30 days can be used.

6. CD4 at screening < or = 200 cells/mL A previous result performed on the last 30 dayscan be used.

7. Subjects can comply with protocol requirements.

8. Subject agrees not to take any medication during the study, includingover-the-counter medicines or herbal preparations, without the approval of the trialphysician.

9. Subject's general medical condition, in the investigator's opinion, does notinterfere with assessments and completion of the study.

10. A female may be eligible to enter and participate in the study if she is notpregnant (as confirmed by serum pregnancy test negative at screening, and a urinenegative test at baseline), not lactating and at least one of the followingcondition applies:

11. Women with non-reproductive potential, defined as pre-menospausal females withdocumented tubal ligation or hysterectomy, or bilateral oophorectomy; or aspost-menospausal women defined as 12 months of spontaneous amenorrhea, and ≥45years of age in women without hormonal replacement therapy.

12. Women with reproductive potential and agrees to follow one of the contraceptiveoptions listed in the Appendix 3 from at least 15 days prior to the first doseof medication and until at least 30 days after the last dose of studymedication and completion of the follow-up visit.

Any contraception method must be used consistently, in accordance with the approved product label. All subjects participating in the study should be counselled on safer sexual practices including the use of effective barrier methods and the choice of effective contraceptive method should be documented in the eCRF.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding, or women who plan to become pregnant in thenext year

2. Subjects testing positive for Hepatitis B surface antigen (+HBsAg) at screening, oranticipated need for Hepatitis C virus (HCV) therapy with drugs with potentialdrug-drug interaction during the study

3. Subjects with severe hepatic impairment (Child-Pugh class C), or unstable liverdisease (ascites, encephalopathy, coagulopathy, or oesophageal or gastric varices)or cirrhosis.

4. Opportunistic infections that impede to start ART immediately (specificallytuberculosis within the first 2 weeks of anti-tuberculosis treatment, and meningealtuberculosis or cryptococcosis within the first month of specific treatment.Subjects with other suspected or confirmed active opportunistic infections andsubjects with tuberculosis or cryptococcal disease after the initial period can beincluded if she/he can follow the protocol and if her/his participation couldbenefit the subject. A clear documentation of these aspects must to be done in theclinical chart of the participant.

5. Subjects who in the investigator's judgment, pose a significant suicidality risk.

6. History or presence of allergy to the study drugs or their components or drugs oftheir class

7. Treatment with any of the following agents within 28 days of screening: radiationtherapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immuneresponses; or treatment with an HIV-1 immunotherapeutic vaccine within 90 days ofscreening; or 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 biologicaleffect of the test agent, whichever is longer, prior to the first dose ofinvestigational product

8. Any previous evidence of resistance to dolutegravir (defined as the presence ofG118R, Q148 H/K/R or R263K), to lamivudine (presence of the mutation M184V) orresistance to tenofovir (mutation K65R or more than 3 TAMs) with a Sanger sequencemethod or using next-generation sequencing (NGS) at a frequency >15%. If the subjectdoes not have a previous resistance test, the investigator can take the samples andrandomize the subject while awaiting the results (see section 4.8 for follow up).

9. Any verified Grade 4 abnormality.

10. Alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin)

11. Creatinine clearance of <50mL/min via Cockroft-Gault method