Trial · NCT01704781
Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART)
NCT01704781, Phase 1, Phase 2, Completed, Bionor Immuno AS; results first posted 2017-03-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART). Trials, record NCT01704781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01704781
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART)
- NCT number
- NCT01704781
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Bionor Immuno AS
- Conditions
- HIV-1 Infection
- Interventions
- Lenalidomide, Lenalidomide placebo, Vacc-4X, rhuGM-CSF
- First posted
- 2012-10-11
- Last updated
- 2017-03-08
- Results first posted
- 2017-03-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity | 31 days | Number of participants in each of the three groups that experienced any dose-limiting toxicity. |
| Primary | Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time | 31 days | |
| Primary | Part B: Change in CD4 Count | Week 26 | Change in CD4 count from baseline to Week 26. |
| Secondary | Part B: Change in CD8 Count | 26 weeks | Change in CD8 count from baseline to week 26. |
| Secondary | Part B: Evaluate the Effect on HIV Viral Load | 26 weeks | Results BLQ (\<20 HIV copies/mL) have been replaced with BLQ/2 = 10 HIV copies/mL while 'not detected' results have been replaced with 0 HIV copies/mL. |
| Secondary | Part B: Incidents of Delayed-type Hypersensitivity | 26 weeks | Delayed-type hypersensitivity measured by induration and erythema. |
| Secondary | Part A and B: Safety and Tolerability | Part A: 31 days and Part B: 26 weeks |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity | 31 days | ITT analysis set was used. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time | 31 days | ITT analysis set was used. | 10^6 cells/mL | MEAN |
| PRIMARY | Part B: Change in CD4 Count | Week 26 | Analysis was performed for both the Intent To Treat (ITT) and Per Protocol (PP) analysis set. | 10^6 cells/L | MEAN |
| SECONDARY | Part B: Change in CD8 Count | 26 weeks | Not all patients had quantifiable blood samples/counts at all time points | 10^6 cells/L | MEAN |
| SECONDARY | Part B: Evaluate the Effect on HIV Viral Load | 26 weeks | ITT analysis set | Copies/mL | MEAN |
| SECONDARY | Part B: Incidents of Delayed-type Hypersensitivity | 26 weeks | The IIT population was used for this outcome measure. Data for one patient was not reported at week 26. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A and B: Safety and Tolerability | Part A: 31 days and Part B: 26 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group71
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity | Part A: Lenalidomide 5 mg | 0 | Participants | ||
| Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity | Part A: Lenalidomide 10 mg | 0 | Participants | ||
| Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity | Part A: Lenalidopmide 25 mg | 0 | Participants | ||
| Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time | Part A: Lenalidomide 5 mg | Baseline | 437.3 | Standard Deviation 38.30 | 10^6 cells/mL |
| Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time | Part A: Lenalidomide 10 mg | Baseline | 436.3 | Standard Deviation 60.05 | 10^6 cells/mL |
| Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time | Part A: Lenalidopmide 25 mg | Baseline | 454.2 | Standard Deviation 86.59 | 10^6 cells/mL |
| Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time | Part A: Lenalidomide 5 mg | Week 1 | 393.0 | Standard Deviation 167.56 | 10^6 cells/mL |
| Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time | Part A: Lenalidomide 10 mg | Week 1 | 317.0 | Standard Deviation 18.52 | 10^6 cells/mL |
| Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time | Part A: Lenalidopmide 25 mg | Week 1 | 342.2 | Standard Deviation 27.13 | 10^6 cells/mL |
| Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time | Part A: Lenalidomide 5 mg | Week 4 | 442.0 | Standard Deviation 121.77 | 10^6 cells/mL |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Lenalidomide 5 mg | 3 | |
| Overall Study | STARTED | Part A: Lenalidomide 10 mg | 3 | |
| Overall Study | STARTED | Part A: Lenalidopmide 25 mg | 6 | |
| Overall Study | STARTED | Part B: Lenalidomide | 12 | |
| Overall Study | STARTED | Part B: Lenalidomide Placebo | 12 | |
| Overall Study | COMPLETED | Part A: Lenalidomide 5 mg | 3 | |
| Overall Study | COMPLETED | Part A: Lenalidomide 10 mg | 3 | |
| Overall Study | COMPLETED | Part A: Lenalidopmide 25 mg | 6 | |
| Overall Study | COMPLETED | Part B: Lenalidomide | 12 | |
| Overall Study | COMPLETED | Part B: Lenalidomide Placebo | 12 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events295
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 | Fatigue | General disorders | Part A: Lenalidomide 5 mg | 1 | 3 | 1 |
| other | Fatigue | General disorders | Part A: Lenalidomide 10 mg | 0 | 3 | 0 |
| other | Fatigue | General disorders | Part A: Lenalidopmide 25 mg | 1 | 6 | 1 |
| other | Fatigue | General disorders | Part B: Lenalidomide | 2 | 12 | 2 |
| other | Fatigue | General disorders | Part B: Lenalidomide Placebo | 4 | 12 | 6 |
| other | Injection site erythema | General disorders | Part A: Lenalidomide 5 mg | 2 | 3 | 4 |
| other | Injection site erythema | General disorders | Part A: Lenalidomide 10 mg | 1 | 3 | 4 |
| other | Injection site erythema | General disorders | Part A: Lenalidopmide 25 mg | 2 | 6 | 2 |
| other | Injection site erythema | General disorders | Part B: Lenalidomide | 4 | 12 | 6 |
| other | Injection site erythema | General disorders | Part B: Lenalidomide Placebo | 2 | 12 | 3 |
1 to 10 of 295Source ClinicalTrials.gov
See all 295 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Lenalidomide 5 mg | ||
| Total, all-cause mortality | Part A: Lenalidomide 10 mg | ||
| Total, all-cause mortality | Part A: Lenalidopmide 25 mg | ||
| Total, all-cause mortality | Part B: Lenalidomide | ||
| Total, all-cause mortality | Part B: Lenalidomide Placebo | ||
| Total, other adverse events | Part A: Lenalidomide 5 mg | 3 | 3 |
| Total, other adverse events | Part A: Lenalidomide 10 mg | 2 | 3 |
| Total, other adverse events | Part A: Lenalidopmide 25 mg | 6 | 6 |
| Total, other adverse events | Part B: Lenalidomide | 10 | 12 |
| Total, other adverse events | Part B: Lenalidomide Placebo | 9 | 12 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01704781
GET https://conductscience.org/api/trials/v1/NCT01704781/results?page=2