A clinical trial to study the effects of newly marketed antiretroviral drug, Tab. Dolutegravir 50 mg, when given along with other Antiretroviral drugs in HIV1 positive individuals

Phase 4

Recruitment & Eligibility

Inclusion Criteria

HIV 1 infected Subjects

Willing and able to understand and provide signed and dated written informed consent after screening.

18 years or older, and adults with weight more than 40 kgs.

HIV-1 positive Subjects who are either.

ART naÃ¯ve

Treatment experienced with NRTIâ??s, NNRTIâ??s , PI and Raltegravir based regimen with Viral load less than 50 copies/ml

Subjects with ART failure having Viral load more than 50 copies/ml

General medical condition does not interfere with trial procedures

Females are eligible if:

They do not plan to become pregnant during the study and next 18 months after baseline

Negative screening pregnancy test and uses one of the following methods:

Abstinence from penile/vaginal intercourse during the study

Double contraceptive methods of which one must be barrier (condom).

Exclusion Criteria

Known hypersensitivity to any of the Anti-retrovirals drugs or components of Dolutegravir based regimen.

Pulmonary tuberculosis and or Extrapulmonary tuberculosis on treatment.

Creatinine clearance less than 30mL per min determined using Cockcroft and Gault formula.

Hepatic impairment of Child Pugh B C.

Treatment with Radiation therapy, cancer chemotherapy or immunomodulator within 28 days of Screening.

Any preexisting psychiatric conditions: depression, bipolar disorders, schizophrenia.

Pregnant and Lactating HIV-1 infected subjects.

Unwilling to give consent for audio recording and unwilling to participate in the study.

Any other Contraindications of the other antiretroviral drugs to be used as backbone therapy

Primary Outcome Measures

Name	Time	Method
Safety <br/ ><br>Incidence rate of AE_ADVERSE EVENTS_ by system organ class and severity <br/ ><br>Frequency and severity of AE_ Clinical and Lab abnormalities <br/ ><br>Intention to treat analysis <br/ ><br>Tolerability <br/ ><br>Number of subjects who discontinue the study treatment due to AE <br/ ><br>Assessed by comparing AE profile among subjects given twice daily vs single dose of dolutegravir and among those with advanced immunosuppression <br/ ><br>Analysis of time to discontinuation of antiretroviral regimen due to any AE <br/ ><br>Timepoint: Causality of AE and SAE would be assessed by using Naranjo Scale and WHO-UMC Causality Categories and assessment criteria. <br/ ><br>Univariable and multivariable analysis would be done to explore risk factors for the development of AE and SAE at 3 months and 6 months

Secondary Outcome Measures