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

Clinical trial of IMOD in HIV/AIDS patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT138904084272N1
Enrollment
15
Registered
2010-08-26
Start date
2010-07-11
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

HIV/ AIDS. Unspecified human immunodeficiency virus [HIV] disease

Interventions

Intrvenous injection of IMOD one vial daily for three months. Each vial contains 4ml IMOD. It will be diluted in 100ml of dextrose 5% solution before injection and will be administered within one hour
Treatment - Drugs

Sponsors

Pars Roos Biotechnology Co.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Syrian Arab Republic

Contacts

Public ContactDr. Faten Alakkad

Clinical trial Department

faten.alakkad@hotmail.com00963112758133

Outcome results

None listed

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