Phase 4
N=30
Raltegravir Intensification in HIV-infected Patients
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00631449 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: 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. — 11; 8 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Raltegravir (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
11; 8 | — |
| SECONDARY Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) From Baseline to Week 24 |
-1.1; -0.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Stable antiretroviral therapy for at least 12 months
- Screening CD4+ T cell count 75 but 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
Data sourced from ClinicalTrials.gov (NCT00631449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.