Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects (CHEER)
This study has been completed.
Sponsor:
Kaiser Permanente
Collaborator:
Merck
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00529243
First received: September 12, 2007
Last updated: June 9, 2011
Last verified: June 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: May 9, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
HIV Infections |
| Intervention: |
Drug: raltegravir |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| A multicenter study that enrolled patients from 11 Kaiser Permanente Human Immunodeficiency Virus (HIV) clinics in California. 54 patients were screened. Two patients did not meet protocol inclusion criteria. |
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 | |
|---|---|
| MK-0518 (Raltegravir) | Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide. |
Participant Flow: Overall Study
| MK-0518 (Raltegravir) | |
|---|---|
| STARTED | 52 |
| COMPLETED | 49 |
| NOT COMPLETED | 3 |
| Adverse Event | 1 |
| Death | 1 |
| Relocated | 1 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| MK-0518 (Raltegravir) | Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide. |
Baseline Measures
| MK-0518 (Raltegravir) | |
|---|---|
|
Number of Participants
[units: participants] |
52 |
|
Age
[units: years] Mean ( Full Range ) |
53
( 40 to 71 ) |
|
Gender
[units: participants] |
|
| Female | 4 |
| Male | 48 |
|
Region of Enrollment
[units: participants] |
|
| United States | 52 |
|
Time of Prior Antiretroviral Therapy Use
[units: years] Mean ( Full Range ) |
15
( 7 to 22 ) |
|
Number of Past Antiretrovials Used
[units: medications] Mean ( Full Range ) |
15
( 4 to 22 ) |
|
Time on Enfuvirtide Therapy
[1] [units: days] Mean ( Full Range ) |
997
( 264 to 2457 ) |
| [1] | mean length of time on enfuvirtide therapy before change to MK-0518 (raltegravir) |
|---|
Outcome Measures
| 1. Primary: | Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24. [ Time Frame: 24 Weeks ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24. |
| Measure Description | To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen. |
| 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. |
|---|
| Analysis used the intent to treat (ITT) population, defined as all patients who received at least one dose of raltegravir. |
Reporting Groups
| Description | |
|---|---|
| MK-0518 (Raltegravir) | Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide. |
Measured Values
| MK-0518 (Raltegravir) | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
52 |
|
Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.
[units: participants] |
49 |
No statistical analysis provided for Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.
| 2. Secondary: | Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24 [ Time Frame: 24 Weeks ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24 |
| Measure Description | To study the immunologic effect of changing enfuvirtide to MK-0518 (raltegravir) in HIV-1 infected patients who have an undetectable level of serum HIV (undetectable serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay)on their current HIV medication regimen. |
| 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. |
|---|
| Analysis was per intention to treat (ITT) population defined as all patients who received at least one dose of raltegravir. |
Reporting Groups
| Description | |
|---|---|
| MK-0518 (Raltegravir) | Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide. |
Measured Values
| MK-0518 (Raltegravir) | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
52 |
|
Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24
[units: cells/mm^3] Mean ( Full Range ) |
32
( -165 to 1362 ) |
No statistical analysis provided for Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24
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 |
|---|
| A limitation of our study was the lack of a separate control arm. However, patients did serve as their own control by virtue of at least 6 months of HIV-1 ribonucleic acid(RNA)levels below the level of quantification before enrollment in the study. |
Results Point of Contact:
Name/Title: William Towner, MD
Organization: Kaiser Permanente
phone: 323-783-7855
e-mail: William.J.Towner@KP.org
Organization: Kaiser Permanente
phone: 323-783-7855
e-mail: William.J.Towner@KP.org
No publications provided
| Responsible Party: | William Towner, MD, Kaiser Permanente |
| ClinicalTrials.gov Identifier: | NCT00529243 History of Changes |
| Other Study ID Numbers: | 4908 |
| Study First Received: | September 12, 2007 |
| Results First Received: | May 9, 2011 |
| Last Updated: | June 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |