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Raltegravir Intensification in HIV-infected Patients

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Raltegravir

Placebo

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Treatment intensification, Low level viremia, Suboptimal CD4+ T cell response, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Stable antiretroviral therapy for at least 12 months
Screening CD4+ T cell count < 350 cells/mm3
All available CD4+ T cell counts in the last year and at screening < 350 cells/mm3
Screening plasma HIV RNA levels below level of detection (< 50 copies RNA/mL using Roche Amplicor or < 75 copies/mL using Bayer bDNA or < 40 copies/mL using Abbott RT-PCR), and all available determinations in past 12 months also below level of detection (isolated single values > 75 but < 1000 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations).
>90% adherence to therapy within the preceding 30 days, as determined by self-report
Both male and female adult (at least 18 years old) subjects are eligible. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.

Exclusion Criteria:

Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason
Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
**Any vaccination 2 weeks prior to baseline (day 0) visit and throughout the study period
Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks
Concurrent treatment with phenobarbital, phenytoin, or rifampin.
Screening absolute neutrophil count <1,000 cells/mm3, platelet count <70,000 cells/mm3, hemoglobin < 8 mg/dL, estimated creatinine clearance <40 mL/minute
Pregnant or breastfeeding women

Sites / Locations

San Francisco General Hospital, Clinical Research Center
San Francisco Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Raltegravir

Placebo

Arm Description

For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.

For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.

Outcomes

Primary Outcome Measures

Number of Participants in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12.

Secondary Outcome Measures

Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) From Baseline to Week 24

Full Information

NCT ID

NCT00631449

First Posted

February 28, 2008

Last Updated

August 5, 2020

Sponsor

University of California, San Francisco

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00631449

Brief Title

Raltegravir Intensification in HIV-infected Patients

Official Title

Raltegravir Intensification in Antiretroviral-treated Patients Exhibiting a Suboptimal CD4+ T Cell Response

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether treatment with Raltegravir further decreases HIV viral replication in HAART-suppressed, HIV-infected patients, potentially improving immune response to antiretroviral therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV, Treatment intensification, Low level viremia, Suboptimal CD4+ T cell response, treatment experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Raltegravir

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Raltegravir

Intervention Description

For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily, in addition to continuing to take their current anti-HIV medicines.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Primary Outcome Measure Information:

Title

Number of Participants in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12.

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) From Baseline to Week 24

Time Frame

Baseline and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Stable antiretroviral therapy for at least 12 months Screening CD4+ T cell count < 350 cells/mm3 All available CD4+ T cell counts in the last year and at screening < 350 cells/mm3 Screening plasma HIV RNA levels below level of detection (< 50 copies RNA/mL using Roche Amplicor or < 75 copies/mL using Bayer bDNA or < 40 copies/mL using Abbott RT-PCR), and all available determinations in past 12 months also below level of detection (isolated single values > 75 but < 1000 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations). >90% adherence to therapy within the preceding 30 days, as determined by self-report Both male and female adult (at least 18 years old) subjects are eligible. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period. Exclusion Criteria: Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason Serious illness requiring hospitalization or parental antibiotics within preceding 3 months **Any vaccination 2 weeks prior to baseline (day 0) visit and throughout the study period Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks Concurrent treatment with phenobarbital, phenytoin, or rifampin. Screening absolute neutrophil count <1,000 cells/mm3, platelet count <70,000 cells/mm3, hemoglobin < 8 mg/dL, estimated creatinine clearance <40 mL/minute Pregnant or breastfeeding women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Deeks, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Francisco General Hospital, Clinical Research Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94110

Country

United States

Facility Name

San Francisco Veterans Affairs Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94121

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21402547

Citation

Hatano H, Hayes TL, Dahl V, Sinclair E, Lee TH, Hoh R, Lampiris H, Hunt PW, Palmer S, McCune JM, Martin JN, Busch MP, Shacklett BL, Deeks SG. A randomized, controlled trial of raltegravir intensification in antiretroviral-treated, HIV-infected patients with a suboptimal CD4+ T cell response. J Infect Dis. 2011 Apr 1;203(7):960-8. doi: 10.1093/infdis/jiq138.

Results Reference

result

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Raltegravir Intensification in HIV-infected Patients

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