A Study on the Efficacy and Side Effects of Softgel-Encapsulated IMOD in Individuals with HIV

Phase 3

Recruiting

• Conditions: +HIV.; Human immunodeficiency virus [HIV] disease

• Registration Number: IRCT20180610040037N5
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Having written informed and voluntary consent.
The patient's age should be between 18 and 65 years.
The patient should have two positive HIV ELISA tests and one positive Western blot test.

Exclusion Criteria

The patient has hepatitis B or C.
Pregnancy or breastfeeding.
Current use of illicit drugs or alcohol.
Use of growth hormone (within 30 days prior to study entry).
Use of testosterone or anabolic steroids (within 30 days prior to study entry).
Long-term treatment with immunosuppressive drugs (except for topical steroids).
Chemotherapy, interferon therapy, or radiotherapy (within three weeks prior to study entry).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CD4 count: The number of CD4 lymphocytes in the blood. Timepoint: 3 months. Method of measurement: Laboratory report.;Laboratory indices of patients : Complete blood cell count/ Alkaline phosphatase level in the blood, measured to assess liver function/ Liver enzymes level in the blood /Blood urea nitrogen (BUN) level, measured to assess kidney function /Blood creatinine level, measured to assess kidney function /Fasting blood glucose level . Timepoint: 3 months. Method of measurement: Laboratory report.;Acute and chronic side effects of oral medication IMOD: Any type of drug-related adverse event based on the physician's diagnosis . Timepoint: 3 months. Method of measurement: Clinical symptoms and physical examination.;Viral load: The number of viruses in the blood. Timepoint: 3 months. Method of measurement: Laboratory report.