Raltegravir Intensification in HIV-infected Patients

NCT00631449 | Completed Phase 4 Results DMC

• 1 other identifier: H52899-31393-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 12

Secondary Outcomes (1)

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

  Baseline and Week 24

Study Arms (2)

Raltegravir

ACTIVE COMPARATOR

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.

Drug: Raltegravir

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Raltegravir DRUG

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.

Raltegravir

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

San Francisco General Hospital, Clinical Research Center

San Francisco, California, 94110, United States

Location

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

Related Publications (1)

• 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.

  PMID: 21402547 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Steven Deeks, MD
• Organization: University of California, San Francisco

Steven.Deeks@ucsf.edu

415-476-4082

Study Officials

• Steven Deeks, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: March 1, 2010
• Last Updated: August 17, 2020
• Results First Posted: December 30, 2013

Record last verified: 2020-08

Locations

US (2)