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| ID | Type | Description | Link |
|---|---|---|---|
| 10136 | Registry Identifier | DAIDS ES | |
| ACTG A5229 |
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Lipoatrophy, the loss of body fat from particular areas of the body, is a common side effect of antiretroviral therapy (ART). The purpose of this study was to determine the effectiveness of uridine supplementation in treating HIV infected individuals on stable ART with lipoatrophy.
Lipoatrophy is a distressing long-term complication of ART and is associated with decreased quality of life, an increased risk of cardiovascular disease, and nonadherence to ART. The cause of lipoatrophy in HIV-infected individuals receiving ART is not completely understood. However, past research suggests that mitochondrial toxicity in subcutaneous adipose tissue caused by thymidine analogue nucleoside analogues may be responsible for the development of lipoatrophy.
Uridine is a nucleoside that has been shown to be an effective supplement in treating individuals with mitochondrial toxicity. NucleomaxX is a food supplement that consists of mitocnol, a sugar cane extract that has a high content of nucleosides, including uridine. The purpose of this study was to evaluate the effects of uridine supplementation in the form of NucleomaxX on limb fat in HIV-infected individuals receiving stable ART containing stavudine (d4T) or zidovudine (ZDV). In addition, this study evaluated the safety and tolerability of NucleomaxX.
This study lasted for 48 weeks. Participants were randomly assigned to one of two treatment arms, stratified by d4T or ZDV use. Arm A participants received NucleomaxX for uridine, while Arm B participants received a placebo for NucleomaxX. Participants in both arms received their assigned intervention three times per day, every other day, for the duration of the study. There were 8 study visits over the 48-week study duration. Blood collection and a physical exam occurred at all study visits, and participants completed an adherence assessment at most visits. Participants underwent dual energy X-ray absorptiometry scans (DEXA) within 14 days prior to or following the screening visit and at other selected visits. Specific fasting tests for glucose and lipid levels occurred at selected visits. ART was not provided by this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NucleomaxX | Active Comparator | Participants received NucleomaxX for 48 weeks |
|
| Placebo | Placebo Comparator | Participants received NucleomaxX placebo for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NucleomaxX | Drug | 36 g sachet taken orally three times daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Limb Fat (g) From Baseline | Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups. | Baseline and Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities) | Time to safety events (grade 3 [Severe] or 4 [life-threatening] sign/symptom or laboratory-based abnormality that is at least one grade higher than baseline) from study entry | Through Week 48 |
| Number of Subjects Discontinuing Study Medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace A. McComsey, MD | Division of Infectious Diseases, Case Western Reserve University | Study Chair |
| Judith A. Aberg, MD | New York University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Therapeutics CRS | Birmingham | Alabama | 35924-2050 | United States | ||
| USC CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14640397 | Background | Koch EC, Schneider J, Weis R, Penning B, Walker UA. Uridine excess does not interfere with the antiretroviral efficacy of nucleoside analogue reverse transcriptase inhibitors. Antivir Ther. 2003 Oct;8(5):485-7. No abstract available. | |
| 16120376 | Background | McComsey GA, Walker UA. Role of mitochondria in HIV lipoatrophy: insight into pathogenesis and potential therapies. Mitochondrion. 2004 Jul;4(2-3):111-8. doi: 10.1016/j.mito.2004.05.008. |
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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).
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | NucleomaxX | Participants received NucleomaxX for uridine through week 48 |
| FG001 | Placebo | Participants received NucleomaxX placebo through week 48 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| NucleomaxX placebo |
| Drug |
36 g placebo sachet taken orally three times daily |
|
Number of eligible subjects who discontinued study medication during the study period. |
| Through Week 48 |
| Change in Limb Fat From Baseline (Week 24 - Baseline) | Limb fat was measured at baseline and visit week 24 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 24 (week 24 - baseline) was estimated for the treatment groups. | Baseline and Week 24 |
| HIV-1 RNA Level | At Week 48 |
| Change in CD4+ Count From Baseline (Week 48 - Baseline) | Baseline and Week 48 |
| Change in Fasting Lactate From Baseline (Week 48 - Baseline) | Baseline and Week 48 |
| Change in Fasting Glucose From Baseline (Week 48 - Baseline) | Baseline and Week 48 |
| Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline) | Baseline and Week 48 |
| Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline) | Baseline and Week 48 |
| Change in Fasting Non-HDL Cholesterol From Baseline (Week 48 - Baseline) | Baseline and Week 48 |
| Change in Fasting Low-density Lipoprotein (LDL) Cholesterol From Baseline (Week 48 - Baseline) | Baseline and Week 48 |
| Change in Fasting Triglycerides From Baseline (Week 48 - Baseline) | Baseline and Week 48 |
| Change in Hemoglobin From Baseline (Week 48 - Baseline) | Baseline and Week 48 |
| Change in Leukocytes From Baseline (Week 48 - Baseline) | Baseline and Week 48 |
| Change in Creatine Kinase From Baseline (Week 48 - Baseline) | Baseline and Week 48 |
| Los Angeles |
| California |
| 90033 |
| United States |
| UCLA CARE Center CRS | Los Angeles | California | United States |
| Stanford CRS | Palo Alto | California | 94305-5107 | United States |
| Ucsd, Avrc Crs | San Diego | California | 92103 | United States |
| Harbor-UCLA Med. Ctr. CRS | Torrance | California | 90502-2052 | United States |
| University of Colorado Hospital CRS | Aurora | Colorado | 80262-3706 | United States |
| The Ponce de Leon Ctr. CRS | Atlanta | Georgia | 30308 | United States |
| Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu | Hawaii | 96816 | United States |
| Rush Univ. Med. Ctr. ACTG CRS | Chicago | Illinois | 60612 | United States |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 46202-5250 | United States |
| Johns Hopkins Adult AIDS CRS | Baltimore | Maryland | 21287-8106 | United States |
| University of Minnesota, ACTU | Minneapolis | Minnesota | 55455 | United States |
| Beth Israel Med. Ctr., ACTU | New York | New York | 10003 | United States |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016-6481 | United States |
| Cornell CRS | New York | New York | 10021 | United States |
| HIV Prevention & Treatment CRS | New York | New York | 10032 | United States |
| Trillium Health ACTG CRS | Rochester | New York | 14607 | United States |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642-0001 | United States |
| Unc Aids Crs | Chapel Hill | North Carolina | 27514 | United States |
| Duke Univ. Med. Ctr. Adult CRS | Durham | North Carolina | 27710 | United States |
| Univ. of Cincinnati CRS | Cincinnati | Ohio | 45267-0405 | United States |
| Case CRS | Cleveland | Ohio | 44106-5083 | United States |
| MetroHealth CRS | Cleveland | Ohio | 44109 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Pitt CRS | Pittsburgh | Pennsylvania | 15213-2582 | United States |
| The Miriam Hosp. ACTG CRS | Providence | Rhode Island | 02906 | United States |
| Vanderbilt Therapeutics CRS | Nashville | Tennessee | 37203 | United States |
| University of Washington AIDS CRS | Seattle | Washington | 98104 | United States |
| Puerto Rico-AIDS CRS | San Juan | 00936-5067 | Puerto Rico |
| 12799554 | Background | Nolan D, Hammond E, Martin A, Taylor L, Herrmann S, McKinnon E, Metcalf C, Latham B, Mallal S. Mitochondrial DNA depletion and morphologic changes in adipocytes associated with nucleoside reverse transcriptase inhibitor therapy. AIDS. 2003 Jun 13;17(9):1329-38. doi: 10.1097/00002030-200306130-00007. |
| 16152713 | Background | Walker UA, Venhoff N. Uridine in the prevention and treatment of NRTI-related mitochondrial toxicity. Antivir Ther. 2005;10 Suppl 2:M117-23. |
| 20827170 | Result | McComsey GA, Walker UA, Budhathoki CB, Su Z, Currier JS, Kosmiski L, Naini LG, Charles S, Medvik K, Aberg JA; AIDS Clinical Trials Group A5229 Team. Uridine supplementation in the treatment of HIV lipoatrophy: results of ACTG 5229. AIDS. 2010 Oct 23;24(16):2507-15. doi: 10.1097/QAD.0b013e32833ea9bc. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NucleomaxX | Participants received NucleomaxX for uridine through week 48 |
| BG001 | Placebo | Participants received NucleomaxX placebo through week 48 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Antiretroviral Therapy Used (Stratification) | Number | Participants |
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| HIV-1 RNA (copies/mL) Category | Number | Participants |
| ||||||||||||||||
| CD4+ Count (NucleomaxX sample size (N)=80, Placebo N=80) | Median | Inter-Quartile Range | Cells/mm^3 |
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| Limb fat | Median | Inter-Quartile Range | Grams |
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| Trunk fat | Median | Inter-Quartile Range | Grams |
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| Fasting lactate (NucleomaxX N=76, Placebo N=75) | Median | Inter-Quartile Range | mmol/L |
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| Fasting glucose (NucleomaxX N=82, Placebo N=82) | Median | Inter-Quartile Range | mg/dL |
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| Fasting total cholesterol (NucleomaxX N=82, Placebo N=81) | Median | Inter-Quartile Range | mg/dL |
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| Fasting high-density lipoprotein (HDL) (NucleomaxX N=82, Placebo N=80) | Median | Inter-Quartile Range | mg/dL |
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| Fasting non-high-density lipoprotein (non-HDL) (NucleomaxX N=77, Placebo N=69) | Median | Inter-Quartile Range | mg/dL |
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| Fasting low-density lipoprotein (LDL) (NucleomaxX N=73, Placebo N=67) | Median | Inter-Quartile Range | mg/dL |
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| Fasting triglycerides (NucleomaxX N=82, Placebo N=81) | Median | Inter-Quartile Range | mg/dL |
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| Hemoglobin | Median | Inter-Quartile Range | g/dL |
| |||||||||||||||
| Leukocytes | Median | Inter-Quartile Range | cells*10^3/L |
| |||||||||||||||
| Creatine kinase (NucleomaxX N=80, Placebo N=82) | Median | Inter-Quartile Range | IU/L |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Limb Fat (g) From Baseline | Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups. | Intention to treat analysis with last observation carried forward (LOCF) if week 48 limb fat data was missing and post-baseline limb fat was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | grams | Baseline and Week 48 |
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| Secondary | Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities) | Time to safety events (grade 3 [Severe] or 4 [life-threatening] sign/symptom or laboratory-based abnormality that is at least one grade higher than baseline) from study entry | As-treated analysis with subjects stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | weeks | Through Week 48 |
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| Secondary | Number of Subjects Discontinuing Study Medication | Number of eligible subjects who discontinued study medication during the study period. | Intention to treat analysis based on all subjects who started study treatment. | Posted | Number | Participants | Through Week 48 |
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| Secondary | Change in Limb Fat From Baseline (Week 24 - Baseline) | Limb fat was measured at baseline and visit week 24 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 24 (week 24 - baseline) was estimated for the treatment groups. | Intention to treat analysis with LOCF if week 24 limb fat data was missing and post-baseline before week 24 limb fat observation was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | grams | Baseline and Week 24 |
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| Secondary | HIV-1 RNA Level | Intention to treat analysis with all randomized subjects. Reduced sample size was due to missing data at week 48. | Posted | Number | Participants | At Week 48 |
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| Secondary | Change in CD4+ Count From Baseline (Week 48 - Baseline) | Intention to treat analysis with LOCF if week 48 CD4+ data was missing and post-baseline data was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | cells/mm3 | Baseline and Week 48 |
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| Secondary | Change in Fasting Lactate From Baseline (Week 48 - Baseline) | Intention to treat analysis with LOCF if week 48 fasting lactate was missing and post-baseline fasting lactate was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | mmol/L | Baseline and Week 48 |
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| Secondary | Change in Fasting Glucose From Baseline (Week 48 - Baseline) | Intention to treat analysis with LOCF if week 48 fasting glucose was missing and post-baseline fasting glucose was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | mg/dL | Baseline and Week 48 |
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| Secondary | Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline) | Intention to treat analysis with LOCF if week 48 fasting total cholesterol was missing and post-baseline fasting total cholesterol was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | mg/dL | Baseline and Week 48 |
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| Secondary | Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline) | Intention to treat analysis with LOCF if week 48 fasting HDL data was missing and post-baseline fasting HDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | mg/dL | Baseline and Week 48 |
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| Secondary | Change in Fasting Non-HDL Cholesterol From Baseline (Week 48 - Baseline) | Intention to treat analysis with LOCF if week 48 fasting non-HDL data was missing and post-baseline fasting non-HDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF or due to associated triglyceride was >400 mg/dL. Subjects were stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | mg/dL | Baseline and Week 48 |
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| Secondary | Change in Fasting Low-density Lipoprotein (LDL) Cholesterol From Baseline (Week 48 - Baseline) | Intention to treat analysis with LOCF if week 48 fasting LDL data was missing and post-baseline fasting LDL was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | mg/dL | Baseline and Week 48 |
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| Secondary | Change in Fasting Triglycerides From Baseline (Week 48 - Baseline) | Intention to treat analysis with LOCF if week 48 fasting triglyceride data was missing and post-baseline fasting triglyceride was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | mg/dL | Baseline and Week 48 |
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| Secondary | Change in Hemoglobin From Baseline (Week 48 - Baseline) | Intention to treat analysis with LOCF if week 48 hemoglobin data was missing and post-baseline hemoglobin was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | g/dL | Baseline and Week 48 |
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| Secondary | Change in Leukocytes From Baseline (Week 48 - Baseline) | Intention to treat analysis with LOCF if week 48 leukocyte data was missing and post-baseline leukocyte was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | cells*10^3/L | Baseline and Week 48 |
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| Secondary | Change in Creatine Kinase From Baseline (Week 48 - Baseline) | Intention to treat analysis with LOCF if week 48 creatine kinase data was missing and post-baseline creatine kinase was available. Reduced sample size was due to missing baseline or missing post-baseline data for LOCF. Subjects were stratified based on ART (d4T or AZT). | Posted | Median | Inter-Quartile Range | IU/L | Baseline and Week 48 |
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From treatment dispensation until off-study with variable participant follow-up time. Overall median (lower quartile, upper quartile) follow-up was 48.0 (47.7, 49.0) weeks.
Grade≥2 nausea, vomiting and diarrhea and all Grade>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events and diseases. All S/Sx or labs that led to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NucleomaxX | Participants received NucleomaxX for uridine through week 48 | 4 | 83 | 75 | 83 | ||
| EG001 | Placebo | Participants received NucleomaxX placebo through week 48 | 2 | 82 | 70 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Blood cholesterol | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Blood cholesterol abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Blood glucose abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Blood lactic acid abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Blood phosphorus decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Blood triglycerides | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Low density lipoprotein abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ACTG ClinicalTrials.gov Coordinator | ACTG Network Coordinating Center, Social and Scientific Systems, Inc. | (301) 628-3313 | ACTGCT.Gov@s-3.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| 40-49 Years |
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| 50-59 Years |
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| 60-69 Years |
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| Male |
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| Black Non-Hispanic |
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| Hispanic (Regardless of Race) |
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| Asian, Pacific Islander |
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| Native American, Alaskan Native |
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| Other (More than One Race) |
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| Unknown |
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| Puerto Rico |
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| d4T-Containing |
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| >50 Copies |
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