Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects (BuLLET)
This study has been completed.
Sponsor:
Felizarta, Franco, M.D.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Felizarta, Franco, M.D.
ClinicalTrials.gov Identifier:
NCT01010399
First received: November 9, 2009
Last updated: March 26, 2012
Last verified: March 2012
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Results First Received: March 26, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Hypertriglyceridemia HIV Infection |
| Interventions: |
Dietary Supplement: Lovaza Drug: fosamprenavir/ritonavir |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Boosted Lexiva With Lovaza | No text entered. |
Participant Flow: Overall Study
| Boosted Lexiva With Lovaza | |
|---|---|
| STARTED | 36 |
| COMPLETED | 31 |
| NOT COMPLETED | 5 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Boosted Lexiva With Lovaza | No text entered. |
Baseline Measures
| Boosted Lexiva With Lovaza | |
|---|---|
|
Number of Participants
[units: participants] |
36 |
|
Age
[units: participants] |
|
| <=18 years | 0 |
| Between 18 and 65 years | 36 |
| >=65 years | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
48.3 ± 6.9 |
|
Gender
[units: participants] |
|
| Female | 1 |
| Male | 35 |
|
Region of Enrollment
[units: participants] |
|
| United States | 36 |
Outcome Measures
| 1. Primary: | Proportion of Subjects With Triglycerides <200 mg/dL [ Time Frame: 24 weeks ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Proportion of Subjects With Triglycerides <200 mg/dL |
| Measure Description | No text entered. |
| Time Frame | 24 weeks |
| Safety Issue | No |
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. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Boosted Lexiva With Lovaza | No text entered. |
Measured Values
| Boosted Lexiva With Lovaza | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
36 |
|
Proportion of Subjects With Triglycerides <200 mg/dL
[units: participants] |
12 |
No statistical analysis provided for Proportion of Subjects With Triglycerides <200 mg/dL
| 2. Secondary: | Proportion of Subjects With HIV-1 RNA <50 Copies/mL [ Time Frame: 24 weeks ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Proportion of Subjects With HIV-1 RNA <50 Copies/mL |
| Measure Description | No text entered. |
| Time Frame | 24 weeks |
| Safety Issue | No |
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. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Boosted Lexiva With Lovaza | No text entered. |
Measured Values
| Boosted Lexiva With Lovaza | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
36 |
|
Proportion of Subjects With HIV-1 RNA <50 Copies/mL
[units: participants] |
28 |
No statistical analysis provided for Proportion of Subjects With HIV-1 RNA <50 Copies/mL
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| 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 |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Franco Felizarta, MD
Organization: Franco Felizarta, MD
phone: 661-324-3128
e-mail: felizarta@pol.net
Organization: Franco Felizarta, MD
phone: 661-324-3128
e-mail: felizarta@pol.net
No publications provided
| Responsible Party: | Felizarta, Franco, M.D. |
| ClinicalTrials.gov Identifier: | NCT01010399 History of Changes |
| Other Study ID Numbers: | COL112948 |
| Study First Received: | November 9, 2009 |
| Results First Received: | March 26, 2012 |
| Last Updated: | March 26, 2012 |
| Health Authority: | United States: Institutional Review Board |