Phase II single arm clinical trial to evaluate safety and efficacy of IMOD in HIV/AIDS patients in Syria

Phase 2

• Conditions: HIV/ AIDS.; Unspecified human immunodeficiency virus [HIV] disease

• Registration Number: IRCT138904084272N1
• Lead Sponsor: Pars Roos Biotechnology Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Inclusion criteria
•Diagnosis of HIV infection (two positive ELISA confirmed by one positive Western Blot test)
•Receiving HAART
•Age more than 18-75
Exclusion criteria
•Evidence of malignancy (diagnosed or presenting a sign or symptom of major cancer such as hemoptysis, chronic cough, rectal bleeding, etc) except for Kaposi’s sarcoma
•Presence of life threatening conditions such as hepatic or renal failure or congestive heart failure
•Presence of life threatening infections or other serious and dangerous infections
•Presence of liver function disorders in laboratory tests including elevation of liver enzymes or Bilirubin level more than 3 times of the upper limit of the normal range
•Drug and alcohol abuse (more than 21 units alcohol for males and 14 units for females)
•Treatment with corticosteroids, immune suppressants, radiotherapy or chemotherapy
•Any known drug hypersensitivity
•Inability or refusal to sign the informed consent
•Receiving any investigational drug within 30 days prior to screening
•Pregnancy or intention of becoming pregnant during the study period

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CD4 Lymphocyte count. Timepoint: At the beginning, First, second, third and fourth month of study. Method of measurement: Flocytometry.

Secondary Outcome Measures

Name	Time	Method
Viral load. Timepoint: At the beginning and end of the study. Method of measurement: Real Time Polymerase Chain Reaction test.;Quality of life. Timepoint: At the beginning and end of the study. Method of measurement: Questionaire.