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Effects of Oral Levamisole as an Adjuvant to Hepatitis B Vaccine for protective antibody production in HIV/AIDS Patients: A Randomized Controlled Trial

Effects of Oral Levamisole as an Adjuvant to Hepatitis B Vaccine for protective antibody production in HIV/AIDS Patients: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT201207275349N2
Enrollment
64
Registered
2012-08-07
Start date
2008-04-02
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. HIV disease resulting in other viral infections

Interventions

Intervention 1: experiment group: Hepatitis B vaccination is perform using Hepavax vaccine 40 microgram for three times with intervals of 0-1-3 months.Levamisole 50 milligram two times a day will b
Prevention
Treatment - Drugs
experiment group: Hepatitis B vaccination is perform using Hepavax vaccine 40 microgram for three times with intervals of 0-1-3 months.Levamisole 50 milligram two times a day will be administered
control group: Hepatitis B vaccination is perform using Hepavax vaccine 40 microgram for three times with intervals of 0-1-3 months.Pelacebo two times a day will be administered form 6 days before

Sponsors

Kermanshah University of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: HIV infection confirmed by positive double ELISA and WB ;Negative history for HBV infection or vaccination include: Negative tests for HBS-Ag, HBS-Ab abd HBC-Ab; Signature of Informed consent form by participant Exclusion criteria: Refuse the study by participant

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Protective HBS-Ab level which is above 10 IU/ml. Timepoint: with the second and the third times of vaccination and one and three months after that, as well. Method of measurement: HBS-Ab measurement by ELISA method.

Secondary

MeasureTime frame
HBS-Ab titre by IU/ml. Timepoint: with the second and the third times of vaccination and one and three months after that, as well. Method of measurement: tittering of HBS-Ab by ELISA method according to IU/ml.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMoayed Alavian

Baqiyatallah Research Center for Gastroenterology and Liver Diseases

editor@hepatmon.ir+98 21 8894 5187

Outcome results

None listed

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