CTRI/2022/02/040532CompletedPhase 2
A Phase II, Multicenter, Randomized, Double Blind, Parallel, PlaceboControlled, Proof of Concept Study to Assess the Antiviral Effect, Safety,Tolerability and Pharmacokinetics of HRF-10071(Test Product, Manufacturedby Hetero Labs Limited, India) in Antiretroviral Treatment-naïve HIV InfectedPatients.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hetero Labs Limited
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Male or Female patients aged of 18 to 45 years (both inclusive).
- •2.Patients willing to give written, signed, and dated informed consent to participate in the study.
- •3.Treatment-naive: No prior intake/ administration of anti-retrovirals (in combination or monotherapy) received after the diagnosis of HIV-1 infection or HBV infection
- •4.Documented HIV infection and Screening plasma HIV-1 RNA >=5000 copies/milliliter (mL).
- •5.Cluster Designation 4 Positive (CD4+) T cell count >=350 cell/mm3 at screening
- •6.Body weight >=50.0 kilograms (kg) for men and >=45.0 kg for women and body mass index (BMI) within the range 18.5-31.0 kg/meter square (kg/m2) (inclusive)
- •7.Subjects who are healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, laboratory tests, and cardiac monitoring.
- •8.Females of childbearing potential who are sexually active must agree to use barrier contraception and can neither be pregnant nor lactating from screening throughout the duration of the study. The serum pregnancy test at screening and urine pregnancy test before dosing on day 01 must be negative for female patients of child bearing potential. Male partners of female patients and male patients should agree to use barrier contraception throughout the study period
Exclusion Criteria
- •1.History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
- •2.Patients with the Hepatitis B surface antigen (HBsAg) and Hepatitis C antibody positive at screening or with 3 months prior to screening.
- •3.Patients with known brain metastasis.
- •4.History of ongoing or clinically relevant hepatitis within the previous 6 months.
- •5.Hemoglobin <10.0 g/dL; Absolute neutrophil count <1000 cells/mm3; platelet count <=100,000 cells/mm3
- •6.Alanine aminotransferase (ALT) >=1.5 times upper limit of normal (ULN); Aspartate aminotransferase (AST) >=1.5 times ULN; Alkaline phosphatase >=1.5 times ULN; bilirubin >ULN.
- •7.Patients with primary HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion.
- •8.Any evidence of viral resistance based on the presence of any major resistance associated mutation (International acquired immunodeficiency syndrome [AIDS] society).
- •9.Historical evidence (prior to study screening period) of the presence of resistance-associated mutations gag.
- •10.Creatinine Clearance <50 mL/minute.
- •11.Active Treatment for a viral infection other than HIV-1, such as Hepatitis B, with an agent that is active against HIV-1
- •12.Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
- •13.Unstable liver disease as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis, known biliary abnormalities with the exception of Gilberts syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment
- •14.Presence of moderate-to-severe hepatic impairment (Class B or C) as determined by Child-Pugh classification.
- •15.A pre existing condition interfering with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease [GERD], gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs or render the patient unable to take oral study treatment.
- •16.Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
- •17.Any Grade 2-4 laboratory abnormality at screening, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides, etc), ALT, AST and ALP (described above)
- •18.Any history of significant underlying psychiatric disorder, including but not limited to schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder.
- •19.Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic ( >6 months) ou20.Any pre existing physical or other psychiatric condition including alcohol or drug abuse, which, in the opinion of the investigator
Investigators
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