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

"Examining the Effectiveness and Side Effects of Softgel-Encapsulated IMOD in Individuals Living with HIV"

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180610040037N5

Enrollment

120

Registered

2023-07-17

Start date

2023-07-23

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

+HIV. Human immunodeficiency virus [HIV] disease

Interventions

Intervention 1: Oral IMOD medication and antiretroviral therapy: The intervention group consists of 60 individuals who will receive treatment with oral IMOD medication containing a combination of Tana

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seyed Ali Dehghan-Maneshadi

Tehran University of Medical Sciences

a_dehghanm@sina.tums.ac.ir+98 21 6658 1583

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026