Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited at AIDS Clinical Trials Units in the United States and Puerto Rico. Recruitment occurred between October 5, 2006 (date first subject was randomized) and January 7, 2008 (date last subject was randomized).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 167 subjects were randomized, and results are reported for 165 eligible participants; two subjects never started study medication and were excluded from all analyses. The subjects were stratified by antiretroviral therapy use, stavudine (d4T) or zidovudine (AZT/ZDV).

Reporting Groups

	Description
NucleomaxX	Participants received NucleomaxX for uridine through week 48
Placebo	Participants received NucleomaxX placebo through week 48

Participant Flow:   Overall Study

	NucleomaxX	Placebo
STARTED	83	82
COMPLETED	68	68
NOT COMPLETED	15	14
Death	1	0
Severe debilitation, unable to continue	1	0
Subject/parent not able to get to clinic	2	1
Withdrawal by Subject	1	8
Not compliant with requirements	4	4
Lost to Follow-up	6	1

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
NucleomaxX	Participants received NucleomaxX for uridine through week 48
Placebo	Participants received NucleomaxX placebo through week 48
Total	Total of all reporting groups

Baseline Measures

	NucleomaxX	Placebo	Total
Overall Participants Analyzed  [Units: Participants]	83	82	165
Age  [Units: Years] Mean (Standard Deviation)	48.4  (7.78)	48.4  (6.46)	48.4  (7.13)
Age, Customized  [Units: Participants]
30-39 Years	9	10	19
40-49 Years	38	32	70
50-59 Years	28	38	66
60-69 Years	8	2	10
Gender  [Units: Participants]
Female	8	7	15
Male	75	75	150
Race/Ethnicity, Customized  [Units: Participants]
White Non-Hispanic	50	52	102
Black Non-Hispanic	11	14	25
Hispanic (Regardless of Race)	15	12	27
Asian, Pacific Islander	3	1	4
Native American, Alaskan Native	3	2	5
Other (More than One Race)	1	0	1
Unknown	0	1	1
Region of Enrollment  [Units: Participants]
United States	81	81	162
Puerto Rico	2	1	3
Antiretroviral Therapy Used (Stratification)  [Units: Participants]
AZT-Containing	63	63	126
d4T-Containing	20	19	39
HIV-1 RNA (copies/mL) Category  [Units: Participants]
<=50 Copies	70	64	134
>50 Copies	13	18	31
CD4+ Count (NucleomaxX sample size (N)=80, Placebo N=80)  [Units: Cells/mm^3] Median (Inter-Quartile Range)	506   (353 to 724)	504   (376 to 710)	506   (359 to 714)
Limb fat  [Units: Grams] Median (Inter-Quartile Range)	3149   (1833 to 4210)	2995   (2082 to 4847)	3037   (2002 to 4403)
Trunk fat  [Units: Grams] Median (Inter-Quartile Range)	8175   (5784 to 10931)	7795   (5327 to 10825)	8114   (5397 to 10898)
Fasting lactate (NucleomaxX N=76, Placebo N=75)  [Units: mmol/L] Median (Inter-Quartile Range)	1.3   (1.0 to 1.7)	1.2   (0.9 to 1.5)	1.3   (0.9 to 1.6)
Fasting glucose (NucleomaxX N=82, Placebo N=82)  [Units: mg/dL] Median (Inter-Quartile Range)	90   (84 to 98)	87   (81 to 95)	89   (82 to 97)
Fasting total cholesterol (NucleomaxX N=82, Placebo N=81)  [Units: mg/dL] Median (Inter-Quartile Range)	194   (163 to 216)	190   (166 to 211)	193   (166 to 215)
Fasting high-density lipoprotein (HDL) (NucleomaxX N=82, Placebo N=80)  [Units: mg/dL] Median (Inter-Quartile Range)	39   (33 to 49)	37   (31 to 47)	38   (32 to 49)
Fasting non-high-density lipoprotein (non-HDL) (NucleomaxX N=77, Placebo N=69)  [Units: mg/dL] Median (Inter-Quartile Range)	139   (123 to 168)	145   (115 to 166)	143   (121 to 167)
Fasting low-density lipoprotein (LDL) (NucleomaxX N=73, Placebo N=67)  [Units: mg/dL] Median (Inter-Quartile Range)	107   (88 to 132)	110   (89 to 127)	109   (88 to 130)
Fasting triglycerides (NucleomaxX N=82, Placebo N=81)  [Units: mg/dL] Median (Inter-Quartile Range)	161   (112 to 237)	165   (114 to 262)	164   (114 to 258)
Hemoglobin  [Units: g/dL] Median (Inter-Quartile Range)	14.9   (13.7 to 15.6)	15.0   (14.0 to 15.8)	14.9   (13.8 to 15.7)
Leukocytes  [Units: cells*10^3/L] Median (Inter-Quartile Range)	5.6   (4.2 to 7.1)	5.5   (4.7 to 7.0)	5.5   (4.5 to 7.0)
Creatine kinase (NucleomaxX N=80, Placebo N=82)  [Units: IU/L] Median (Inter-Quartile Range)	125   (79 to 216)	142   (88 to 247)	134   (84 to 231)

1.  Primary:

Change in Limb Fat (g) From Baseline   [ Time Frame: Baseline and Week 48 ]

2.  Secondary:

Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities)   [ Time Frame: Through Week 48 ]

3.  Secondary:

Number of Subjects Discontinuing Study Medication   [ Time Frame: Through Week 48 ]

4.  Secondary:

Change in Limb Fat From Baseline (Week 24 - Baseline)   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:

HIV-1 RNA Level   [ Time Frame: At Week 48 ]

6.  Secondary:

Change in CD4+ Count From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

7.  Secondary:

Change in Fasting Lactate From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

8.  Secondary:

Change in Fasting Glucose From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

9.  Secondary:

Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

10.  Secondary:

Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

11.  Secondary:

Change in Fasting Non-HDL Cholesterol From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

12.  Secondary:

Change in Fasting Low-density Lipoprotein (LDL) Cholesterol From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

13.  Secondary:

Change in Fasting Triglycerides From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

14.  Secondary:

Change in Hemoglobin From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

15.  Secondary:

Change in Leukocytes From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

16.  Secondary:

Change in Creatine Kinase From Baseline (Week 48 - Baseline)   [ Time Frame: Baseline and Week 48 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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