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PHOTOTHERAPY A LIFE SAVING FORM OF TREATMENT
PRESENTED BY DR. DAN FERNANDEZ

PRELIMINARY PROTOCOL RESULTS

PROTOCOL PCI-001-04
DURATION OF STUDY: 3 MONTHS

STUDY DESIGN AND METHODOLOGY:

	This was a simple pilot randomized clinical trial where 36 ARC Related HIV/AIDS subjects were chosen to receive between 0.1 - 1.0 J/cm² of PCI weekly for 5 weeks and then once every other week until 3 months of treatment were completed.
	Laboratory studies included a complete Chemical Profile, CBC, Viral Loads, CD4/CD8 counts, Liver Profile, Cardiac Profile, Sedimentation, Hepatitis, Tuberculosis, Pregnancy and Urine Analysis.
	Diagnostic tests included periodic chest X-Rays, EKG’s, Spirometry Lung Compliance testing and a Body Composition Analyzer.

PRIMARY OBJECTIVES :

	Demonstrate the efficiency in VIVO of PCI for the treatment of HIV/AIDS.
	Demonstrate Viral Load Reductions comparable to those observed by Retroviral Medications.
	Demonstrate an increase in CD4/CD8 counts to normal.
	Demonstrate an increase in the quality of life.
	Observe and report any side effects notes during the study.

SECONDARY OBJECTIVES :

Determine the efficacy of PCI in treating VIH 1/2 in a PHASE III study.

CLASSIFICATION by AGE

	FROM 18 – 30 YEARS OLD 12 PATIENTS
	FROM 31 – 40 YEARS OLD 16 PATIENTS
	FROM 41 – 51 YEARS OLD   8 PATIENTS
	TOTAL:  36 PATIENTS

RESULTS AT 3 MONTHS

	DECREASES IN VIRAL LOAD 30
	PROGRESSION IN VIRAL LOAD 6
	OF 36 SUBJECTS 30 DEMONSTRATED A DECREASE IN IN VIRAL LOAD AT 3 MONTHS.
	AN 84% SUCCESS RATE
After a treatment the virus fragments and demonstrates higher than normal levels of Viral Loads. Dr. Fernandez believes that a study of 6 months duration would demonstrate Viral Load reductions in 100% of the subjects.

RESULTS AT 3 MONTHS
PERCENTAGE OF DECREASE IN VIRAL LOADS IN 30 PATIENTS:

PROTOCOL PCI-001-04 COMPARISON STUDY
STUDIES DECREASE PROGRESSION

STUDIES DECREASE PROGRESSION ROCHE 116A (8 WEEKS) 52% 48% ROCHE 116A (16 WEEKS) 46% 54% ROCHE 116B/117 (8 WEEKS) 55% 45% ROCHE 116B/117 (16 WEEKS)  55% 45%           GMT-PCI 2004-001 (4 WEEKS) 58% 42% GMT-PCI 2004-001 (8 WEEKS) 76%  24% GMT-PCI 2004-001  (12 WEEKS)  84% 16%

ROCHE REGIMEN: 1 DOSE OF ZDV, AND 2 DOSES OF ddl

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