Carbohydrate-derived fulvic acid wellness drink: its tolerability, safety and effect on disease markers in pre-ART HIV-1 positive subjects

Figures & data

Table 1: Patient demographics at screening and last available visit

	Inclusion
Demographic data at inclusion	Placebo	Active
Age (mean)	39.2	36.5
Gender:
Male (n)	90	89
Female (n)	76	77
HIV-1 (mean time since diagnosis in years)	2.56	2.11

Mean change in parameters over time	Placebo at inclusion	Active at inclusion	Placebo last available visit *	Active last available visit *
CD4 (mean cells/mm^3)	419	413	447	449
Viral load (mean log)	3.62	3.59	3.56	3.33
Creatinine (mean)	0.917	0.847	0.88	0.86
GGT (mean mmol/l)	35.2	33.3	42.23 (37.71†)	36.19
SGOT (mean mmol/l)	28.8	28.7	31.2	28.9
Haemoglobin (mean mg/dl)	13.1	13.1	13.1	13.0

Note: From this table it is clear that there was no significant difference between the two arms at study initiation and study end.

* The last available visit is the last visit for the patient before the study termination date that was not the screening visit and that had a valid measurement for the parameter.

^† One patient had a very high GGT value of 674. The value in parentheses shows the average when this outlier is removed.

Figure 1: Total number of patients who went for each visit prior to study termination.

Note: The study is highly censored after the 6th and 7th visits due to early termination of the study. The graph show patients per visit as some patients skipped some visits and others stopped before final visit or study completion. The report is however on all recruited patients (ITT analyses). Data is of patient who had at least two visits.

Figure 2: Summary of CD4 changes from baseline superimposed on anticipated decline.

Notes: The black line indicates the anticipated CD4 decline of between 70 and 90 cells per mm3 per year. The blue line was fitted to the observed data from the trial. The 95% confidence interval of change in CD4 count per year for the population as a whole is an increase of between 23.66 and 66.21 cell per mm³ per year.

Table 2: Detailed discontinuation reasons per patient

Item	Active	Placebo	Sum
ART initiated	4	3	7*
Became ineligible**	0	1	1
CD4 250 (reached stopping criteria at level of count)	4	8	12*
CD4 350 (reached stopping criteria at level of count)	5	2	7*
CD4 threshold (reached stopping criteria as per rate in decline in CD4)	2	5	7*
Completed visits	26	18	44
Consent withdrawn	17^#	8	25^†
Continuing	1	3	4
CD4 decline by 100 cells	1	2	3*
Liver enzymes high	0	7	7
Lost to follow-up	34	35	69^‡

* From this table it is obvious that only 36 events occurred.

** Patients becoming non-compliant or missing two visits in a row.

^† More patients withdrew consent on active treatment.

^‡ The numbers lost to follow-up were no different in the two groups. #Patients could with draw consent without stating a reason (mostly due to taste).

Table 3: Event summary

Item	Active	Placebo	Total
Total	16	20	36
Female	7	13	20
Male	9	7	16
Site 1	3	3	6 (9%)
Site 2*	5	3	8 (6.3%)
Site 3	5	12	17 (16.7%)
Site 4	3	2	5 (13.9%)

Note: Items in parentheses indication ratio to number of patients per site.

* Site 2 had 127 patients but lowest ratio.

Table 4: Number of patients per treatment arm that reported adverse events

Item	Active	Placebo	Sum
Acute nasopharyngitis (common cold)	8	11	19
Myalgia	6	6	12
Cough	4	6	10
Fever of unknown origin	3	5	8
Headache	6	2	8
Diarrhoea unspecified	5	2	7
Gastritis simple	4	1	5
Pain in lower limb unspecified	1	4	5
Nausea and vomiting	4	0	4
Pruritus	1	3	4
Abnormal results of liver function studies	0	3	3
Anorexia	2	1	3
Herpes zoster	2	1	3
Lower back pain	1	2	3
Weakness non-specific	3	0	3

Note: This table lists the adverse events reported where the total number was more than two. As can be seen, the gastrointestinal adverse events (diarrhoea) as well as headaches were more frequently reported in the active treatment arm; this was, however, not significantly different between the groups.