Human immunodeficiency virus [HIV] disease. Unspecified human immunodeficiency virus [HIV] disease
Conditions
Interventions
HIV positive patients confirm by Western Blot test who need antiviral treatment will recruit in our study.
Drug efficacy and side effect will observe by physical exam (Medical Doctor) and lab test..
Treatment - Drugs
HIV positive patients confirm by Western Blot test who need antiviral treatment will recruit in our study.
Drug efficacy and side effect will observe by physical exam (Medical Doctor) and lab test.
Sponsors
Pars Roos Co
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: These patients are divided into two groups. The first group consists of six patients with CD4+ count of =200 and <350. The CD4+ count value in the second group is =350 and <500. Inclusions Criteria 1- HIV-1-infected adults aged 18-65 years old 2- Asymptomatic HIV positive patients 3- Patients naïve to any antiretroviral or immunomodulatory therapy 4- Plasma HIV-1 RNA of =1000 copies/mL 5- For the first group, CD4+ T-cell count =200 and <350 and for the second group, CD4+ T-cell count =350 and <500. 6- Adequate hematologic function (absolute neutrophil count =1000/µL, platelets =50×103/µL, hemoglobin =8.0 g/dL) 7- Adequate hepatic function (transaminases =3 × upper limit of normal. consent Exclusions Criteria 1- Patients with any medical conditions or required medications that may compromise their safety or interfere with drug absorption. 2- Patients with hepatitis B and C antigen. 3- Required use of prohibited medications (CD4+ <200 is the indication of HAART according to the Iranian therapeutic guideline). 4- Creatinine clearance estimated by the Cockcroft-Gault equation of <50 mL/min. 5- Pregnancy or breast-feeding. 6- Concurrent HSV infection. 7- Active drug abuse or alcohol consumption. 8- Any application history of immunomodulator and HIV or tropical diseases vaccines. 9- Use of any investigational therapy within 6 months prior to study. 10- Use of human growth hormone within 30 days prior to study entry.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T lymphocyte CD4 count. Timepoint: baseline and weeks: 2, 4, 8, 12, 24, 30 and 36 from the begining of the study. Method of measurement: Lab test.;Viral Load. Timepoint: baseline and weeks: 2, 4, 8, 12, 24, 30 and 36 from the begining of the study. Method of measurement: Lab test/ RTPCR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Appearance of any drug side effects. Timepoint: Performed at each visit. Method of measurement: Regular clinical and laboratory assessments and filling out their relevant questionnaires. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyed Ahmad Seyed Alinaghi
Iranian Research center for HIV/AIDS
Outcome results
None listed