Trial · NCT00307164
Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy
NCT00307164, Phase 2, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2011-10-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy. Trials, record NCT00307164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00307164
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of a Uridine Supplement on HIV Infected Adults With Lipoatrophy
- NCT number
- NCT00307164
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 167 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV Infections, Lipoatrophy
- Interventions
- NucleomaxX, NucleomaxX placebo
- First posted
- 2006-03-27
- Last updated
- 2021-11-04
- Results first posted
- 2011-10-04
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Limb Fat (g) From Baseline | Baseline and Week 48 | 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. |
| Secondary | Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities) | Through Week 48 | 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 |
| Secondary | Number of Subjects Discontinuing Study Medication | Through Week 48 | Number of eligible subjects who discontinued study medication during the study period. |
| Secondary | Change in Limb Fat From Baseline (Week 24 - Baseline) | Baseline and Week 24 | 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. |
| Secondary | HIV-1 RNA Level | At Week 48 | |
| Secondary | Change in CD4+ Count From Baseline (Week 48 - Baseline) | Baseline and Week 48 | |
| Secondary | Change in Fasting Lactate From Baseline (Week 48 - Baseline) | Baseline and Week 48 | |
| Secondary | Change in Fasting Glucose From Baseline (Week 48 - Baseline) | Baseline and Week 48 | |
| Secondary | Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline) | Baseline and Week 48 | |
| Secondary | Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline) | Baseline and Week 48 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Limb Fat (g) From Baseline | Baseline and Week 48 | 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). | grams | MEDIAN |
| SECONDARY | Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities) | Through Week 48 | As-treated analysis with subjects stratified based on ART (d4T or AZT). | weeks | MEDIAN |
| SECONDARY | Number of Subjects Discontinuing Study Medication | Through Week 48 | Intention to treat analysis based on all subjects who started study treatment. | Participants | NUMBER |
| SECONDARY | Change in Limb Fat From Baseline (Week 24 - Baseline) | Baseline and Week 24 | 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). | grams | MEDIAN |
| SECONDARY | HIV-1 RNA Level | At Week 48 | Intention to treat analysis with all randomized subjects. Reduced sample size was due to missing data at week 48. | Participants | NUMBER |
| SECONDARY | Change in CD4+ Count From Baseline (Week 48 - Baseline) | Baseline and Week 48 | 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). | cells/mm3 | MEDIAN |
| SECONDARY | Change in Fasting Lactate From Baseline (Week 48 - Baseline) | Baseline and Week 48 | 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). | mmol/L | MEDIAN |
| SECONDARY | Change in Fasting Glucose From Baseline (Week 48 - Baseline) | Baseline and Week 48 | 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). | mg/dL | MEDIAN |
| SECONDARY | Change in Fasting Total Cholesterol From Baseline (Week 48 - Baseline) | Baseline and Week 48 | 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). | mg/dL | MEDIAN |
| SECONDARY | Change in Fasting High-density Lipoprotein (HDL) Cholesterol From Baseline (Week 48 - Baseline) | Baseline and Week 48 | 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). | mg/dL | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Limb Fat (g) From Baseline | NucleomaxX | 74 | Inter-Quartile Range -206 to 344 | grams | |
| Change in Limb Fat (g) From Baseline | Placebo | 110 | Inter-Quartile Range -202 to 393 | grams | |
| Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities) | NucleomaxX | 47.1 | Inter-Quartile Range 17.6 to 48.7 | weeks | |
| Time to Safety Events (Signs/Symptoms or Laboratory Abnormalities) | Placebo | 47.9 | Inter-Quartile Range 34.1 to 48.7 | weeks | |
| Number of Subjects Discontinuing Study Medication | NucleomaxX | 34 | Participants | ||
| Number of Subjects Discontinuing Study Medication | Placebo | 34 | Participants | ||
| Change in Limb Fat From Baseline (Week 24 - Baseline) | NucleomaxX | 54 | Inter-Quartile Range -117 to 315 | grams | |
| Change in Limb Fat From Baseline (Week 24 - Baseline) | Placebo | 7 | Inter-Quartile Range -202 to 238 | grams | |
| HIV-1 RNA Level | NucleomaxX | <=50 copies/ml | 59 | Participants | |
| HIV-1 RNA Level | Placebo | <=50 copies/ml | 54 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NucleomaxX | 83 | |
| Overall Study | STARTED | Placebo | 82 | |
| Overall Study | COMPLETED | NucleomaxX | 68 | |
| Overall Study | COMPLETED | Placebo | 68 | |
| Overall Study | NOT COMPLETED | NucleomaxX | 15 | |
| Overall Study | NOT COMPLETED | Placebo | 14 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | NucleomaxX | 11 | 83 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 7 | 82 | |
| other | Nausea | Gastrointestinal disorders | NucleomaxX | 16 | 83 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 6 | 82 | |
| other | Vomiting | Gastrointestinal disorders | NucleomaxX | 7 | 83 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 3 | 82 | |
| other | Alanine aminotransferase increased | Investigations | NucleomaxX | 5 | 83 | |
| other | Alanine aminotransferase increased | Investigations | Placebo | 4 | 82 | |
| other | Blood bilirubin increased | Investigations | NucleomaxX | 8 | 83 | |
| other | Blood bilirubin increased | Investigations | Placebo | 7 | 82 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NucleomaxX | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | NucleomaxX | 75 | 83 |
| Total, other adverse events | Placebo | 70 | 82 |
| Total, serious adverse events | NucleomaxX | 4 | 83 |
| Total, serious adverse events | Placebo | 2 | 82 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NucleomaxX vs Placebo: Number of Subjects Discontinuing Study Medication | Trial comparisons |
| NucleomaxX vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00307164
GET https://conductscience.org/api/trials/v1/NCT00307164/results?page=2