Trial · NCT01384734
HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
NCT01384734, Phase 2, Completed, ViiV Healthcare; results first posted 2018-11-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections. Trials, record NCT01384734. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01384734
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
- NCT number
- NCT01384734
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 254 participants, actual
- Lead sponsor
- ViiV Healthcare
- Conditions
- Infection, Human Immunodeficiency Virus
- Interventions
- BMS-663068 400 mg, BMS-663068 800 mg, BMS-663068 600 mg, BMS-663068 1200 mg, Raltegravir 400 mg, Tenofovir 300 mg, Ritonavir 100 mg, Atazanavir 300 mg
- First posted
- 2011-06-29
- Last updated
- 2018-11-14
- Results first posted
- 2018-11-14
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24 | Week 24 | Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. Intent-To-Treat-Exposed (ITT-E) Population includes all randomized participants who received at least one dose of study treatment. |
| Primary | Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24 | Up to Week 24 | Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety population included all participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week 24 included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 24 visit snapshot window. |
| Secondary | Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period | Baseline and up to Day 8 of the monotherapy period | Change from monotherapy Baseline in log10 HIV RNA to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. ITT-E Monotherapy Population comprised of participants that were randomized and participated in the monotherapy sub-study and received at least one dose of FTR Monotherapy. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Secondary | Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA | Baseline and up to Day 8 of the monotherapy period | Maximum decrease from monotherapy Baseline in log10 plasma HIV-1 RNA during monotherapy to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. The data for monotherapy nadir has been presented where nadir represents the maximum decrease from Baseline. |
| Secondary | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period | Up to Day 8 of the monotherapy period | Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Baseline of combination therapy was assessed to evaluate the antiviral activity of four doses of FTR. Baseline of combination therapy was the Day 1 of the combination therapy. Virologic success or failure was determined using the non-missing viral load value at Baseline of combination therapy. The assessment closest to the window target Study Day was used for the analysis. Only those participants with data available at the specified time points were analyzed. |
| Secondary | Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period | Up to Day 8 of the monotherapy period | Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. |
| Secondary | Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy | Baseline and Day 8 | Blood was collected and CD4+ and CD8+ cell count assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. |
| Secondary | Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy | Baseline and Day 8 | Blood was collected and CD4+ and CD8+ proportion assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. |
| Secondary | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study | Weeks 48 and 96 | Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage CI. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. |
| Secondary | Number of Participants With SAE and Discontinuation Due to AEs During Primary Study | Weeks 48 and 96 | Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety Population comprised of participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week X (where X = 48 or 96) included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 48 and 96 visit snapshot window. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24 | Week 24 | ITT-E Population | Percentage of Participants | NUMBER |
| PRIMARY | Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24 | Up to Week 24 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period | Baseline and up to Day 8 of the monotherapy period | ITT-E Monotherapy Population | log10 c/mL | MEAN |
| SECONDARY | Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA | Baseline and up to Day 8 of the monotherapy period | ITT-E Monotherapy Population | log10 c/mL | MEAN |
| SECONDARY | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period | Up to Day 8 of the monotherapy period | ITT-E Monotherapy Population | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period | Up to Day 8 of the monotherapy period | ITT-E Monotherapy Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy | Baseline and Day 8 | ITT-E Monotherapy Population | cells per cubic millimeter | MEAN |
| SECONDARY | Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy | Baseline and Day 8 | ITT-E Monotherapy Population | cells per cubic millimeter | MEAN |
| SECONDARY | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study | Weeks 48 and 96 | ITT-E Population | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With SAE and Discontinuation Due to AEs During Primary Study | Weeks 48 and 96 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group169
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24 | FTR 400 mg BID/RAL/TDF | 80 | 95% Confidence Interval 66.3 to 90.0 | Percentage of Participants | |
| Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24 | FTR 800 mg BID/RAL/TDF | 69 | 95% Confidence Interval 54.6 to 81.7 | Percentage of Participants | |
| Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24 | FTR 600 mg QD/RAL/TDF | 76 | 95% Confidence Interval 62.5 to 87.2 | Percentage of Participants | |
| Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24 | FTR 1200 mg QD/RAL/TDF | 72 | 95% Confidence Interval 57.5 to 83.8 | Percentage of Participants | |
| Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24 | ATV/r/RAL/TDF | 75 | 95% Confidence Interval 60.4 to 85.7 | Percentage of Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24 | FTR 400 mg BID/RAL/TDF | SAE | 3 | Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24 | FTR 800 mg BID/RAL/TDF | SAE | 4 | Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24 | FTR 600 mg QD/RAL/TDF | SAE | 4 | Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24 | FTR 1200 mg QD/RAL/TDF | SAE | 2 | Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24 | ATV/r/RAL/TDF | SAE | 5 | Participants |
1 to 10 of 169Source ClinicalTrials.gov
See all 169 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FTR 400 mg BID/RAL/TDF | 50 | |
| Overall Study | STARTED | FTR 800 mg BID/RAL/TDF | 49 | |
| Overall Study | STARTED | FTR 600 mg QD/RAL/TDF | 51 | |
| Overall Study | STARTED | FTR 1200 mg QD/RAL/TDF | 50 | |
| Overall Study | STARTED | ATV/r/RAL/TDF | 51 | |
| Overall Study | COMPLETED | FTR 400 mg BID/RAL/TDF | 33 | |
| Overall Study | COMPLETED | FTR 800 mg BID/RAL/TDF | 25 | |
| Overall Study | COMPLETED | FTR 600 mg QD/RAL/TDF | 28 | |
| Overall Study | COMPLETED | FTR 1200 mg QD/RAL/TDF | 22 | |
| Overall Study | COMPLETED | ATV/r/RAL/TDF | 22 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events160
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 | Nasopharyngitis | Infections and infestations | FTR/RAL/TDF Total | 32 | 200 | 52 |
| other | Nasopharyngitis | Infections and infestations | ATV/r/RAL/TDF | 5 | 51 | 10 |
| other | Upper respiratory tract infection | Infections and infestations | FTR/RAL/TDF Total | 27 | 200 | 47 |
| other | Upper respiratory tract infection | Infections and infestations | ATV/r/RAL/TDF | 7 | 51 | 7 |
| other | Urinary tract infection | Infections and infestations | FTR/RAL/TDF Total | 28 | 200 | 62 |
| other | Urinary tract infection | Infections and infestations | ATV/r/RAL/TDF | 6 | 51 | 19 |
| other | Influenza | Infections and infestations | FTR/RAL/TDF Total | 22 | 200 | 43 |
| other | Influenza | Infections and infestations | ATV/r/RAL/TDF | 7 | 51 | 8 |
| other | Bronchitis | Infections and infestations | FTR/RAL/TDF Total | 22 | 200 | 34 |
| other | Bronchitis | Infections and infestations | ATV/r/RAL/TDF | 4 | 51 | 4 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FTR/RAL/TDF Total | 3 | 200 |
| Total, all-cause mortality | ATV/r/RAL/TDF | 0 | 51 |
| Total, other adverse events | FTR/RAL/TDF Total | 163 | 200 |
| Total, other adverse events | ATV/r/RAL/TDF | 46 | 51 |
| Total, serious adverse events | FTR/RAL/TDF Total | 35 | 200 |
| Total, serious adverse events | ATV/r/RAL/TDF | 8 | 51 |
Source ClinicalTrials.gov
Papers4
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 |
|---|---|
| FTR/RAL/TDF Total vs ATV/r/RAL/TDF: deaths from any cause | Trial comparisons |
| FTR/RAL/TDF Total vs ATV/r/RAL/TDF: 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/NCT01384734
GET https://conductscience.org/api/trials/v1/NCT01384734/results?page=2