Raltegravir Intensification in HIV-infected Patients

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631449
• Other study ID #: H52899-31393-03
• Status: Completed
• Phase: Phase 4
• Start date: February 2008
• Est. completion date: March 2010

Study information

• Verified date: August 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Raltegravir
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	San Francisco General Hospital, Clinical Research Center	San Francisco	California
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & 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 wi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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