A clinical trial of Nutraceutical product as self medication on HIV patients to check the effect on prolongation of the pre â?? ART phase
- Conditions
- Health Condition 1: null- HIV positive, AntiRetroviral Therapy naïve subjects
- Registration Number
- CTRI/2012/01/002324
- Lead Sponsor
- Vihoton Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 460
Male or female outpatients aged 18 years and over.
Subjects must give consent to participate in the study. All subjects must understand all aspects of the protocol and must receive a signed copy of the informed consent document.
Subjects must be known and confirmed HIV-1 positive who are healthy or present at most with stage 1 or 2 disease (according to WHO criteria in Appendix C) with a CD4 count between 250 cells/mm3 and 550 cells/mm3. Country specific guidelines will determine the CD4 count for inclusion i.e. 250 cells/mm3 in India and 350 cells/ mm3
Subjects must be ART-naïve (including subjects who received less than 1 month continuous ART more than 1 year ago).
Females of childbearing potential are eligible if they are not sexually active or if they follow a medically accepted contraceptive method (e.g. hormonal birth control for at least 2 months prior to the start of the study). Sexually active male and female subjects may also use two barrier methods or one barrier method with a spermicide, or an intrauterine device.
Subjects must be able to complete the questionnaire and understand all aspects pertaining to the study as to discuss it with the study investigator. Note: if a subject is illiterate, the site counsellor / Investigator may discuss the questions with the subject and may provide the responses however, the counsellor/ Investigator may not answer for the subject. The counsellor / Investigator must also be available at all study visits and must be blinded to the treatment group. (The presence of the third party must be consented to and noted as such in source)
Subjects must be otherwise healthy with no other systemic disease that can influence the immune response, e.g. cancer, psoriasis, rheumatoid arthritis etc.
The liver enzyme markers (AST and GGT) of the subject should be within twice the upper limit of the normal country/lab specific range.
A negative urine pregnancy test must be confirmed
Subjects must be willing to comply with all scheduled visits and procedures
Pregnancy or breast/feeding or sexually active women not using medically accepted contraceptive method.
Systemic uncontrolled diseases such as cancer, psoriasis, diabetes mellitus, kidney failure, liver failure, auto-immune diseases, haematologic diseases, GIT conditions, cardiovascular or lung disease which significantly compromise the subjectsâ?? health and any immune system disease other than atopy (e.g. hay fever).
Chronic diarrhoea that may lead to malabsorbtion.
Malignancies that require therapy.
Acute or chronic HIV related opportunistic infection which may mandate initiation of ART therapy.
Subjects with psychiatric diseases or deviations.
CD4 count at baseline of less than 250 cells/mm3 or 350 cells/mm3 (Country specific i.e. 250 cells/ mm3 in India and 350 cells/ mm3 in South Africa.)
Haemoglobin level of lower than 8 g/dL.
Abnormal levels of proteinuria of not more than 1gram per day or serum creatinine that is considered clinically significant.
Liver enzyme markers of the subject more than twice the upper limit of the normal range.
Active alcohol or substance abuse i.e. clinically significant.
Medications prohibited throughout the study, including herbal medications, (including products such as St. Johnâ??s Wort), and other immunosuppressant such as cyclosporine and systemic corticosteroids etc. Please note that topical and inhaled corticosteroids are permitted.
Subjects that already use CHD-FA for self medication.
Subjects must not have used any fulvic acid products within in the previous 3 months.
The inability to tolerate oral medication
Expected non-compliance
Subjects not able to give informed consent
Subjects not able to document or fill in/record symptoms on a diary card.
(If a subject is illiterate, this exclusion is not applicable under the following circumstance:
•Where a family member has completed the Diary card on behalf on the Subject
•The Diary Card completion is verified by the site counsellor who may discuss the questions with the subject and may provide the responses not already completed however, the counsellor may not answer for the subject. The counsellor must also be available at all study visit and must be blinded to the treatment group)
Subjects already included in another study
Subjects related to investigators or in their employ
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is to compare the time until the decision to commence ART by the relevant clinician and or the subjectâ??s CD4 count have decreased by 100 cells/mm3, in the two treatment groupsTimepoint: The time from the start of the study for each subject until the day of initiation of ART and or the day when a decrease in CD4 count of 100 cells/mm3 or more was first detected, for the same subject will be used in the analysis of this outcome
- Secondary Outcome Measures
Name Time Method CD4 cell count, viral load and safety parameters (calculated serum creatinine, proteinuria, AST and GGT) will be analysedTimepoint: week 12, 24, 36, 48, 60, 72, 84 and 96 (± 5 days);The RAND SF-36 quality of life survey will be completed by each subject at randomisation visit before start of treatment, at specified times during the study and at end of study visit in order to determine the effect of FH0210 on the general well-being of pre-ART HIV positive patients.Timepoint: Randomization, week 12, 24, 36, 48, 60, 72, 84 and 96 (± 5 days)