Phase 2
Completed N=44
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects
Source: ClinicalTrials.gov NCT00654147 ↗Enrolled (actual)
44
Serious AEs
9.1%
Results posted
Jul 2015
Primary outcomePrimary: Time to Confirmed Virologic Failure — 28; 29 weeks
Summary
A prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the protease inhibitor lopinavir/ritonavir (LPV/r) and a three drug regimen with Raltegravir and two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.
Immunology Substudy added to determine the kinetics of recovery of CD4 T cells and subpopulations (regulatory T cell [T regs], TH-17 and TH1) after treatment initiation with Raltegravir based regimens and their relationship with functional CD8 T cells and if Raltegravir containing therapies leads to decreases in markers of gut microbial translocation and of cellular and soluble markers of immune activation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Confirmed Virologic Failure |
28; 29 | — |
| PRIMARY Time to Virologic Failure |
3.2296; 2.9952 | — |
| SECONDARY Study Medication Toxicity-related Discontinuation . |
1; 0 | — |
| SECONDARY Weeks to HIV-1 RNA <200 Copies/ml |
28; 28; 56; 56 | — |
| SECONDARY Change From Baseline CD4+ and CD8+ Cell Counts |
516.34; 452.11; 521.31; 482.36 | — |
| SECONDARY Study Medication Tolerability |
1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Documented HIV Infection
- Genotypic resistance without major resistance mutations within 30 days
- Antiretroviral drug-naïve
- Screening HIV-1 RNA ≥5000
- Women of reproductive potential
- Negative pregnancy test within 48 hours
Exclusion Criteria
- Acute or recent HIV-1 infection
- Currently breast feeding
- Use of immunomodulators
- Evidence of major resistance mutations
- HBsAg positive
- Acute hepatitis of any etiology or clinically significant liver disease
- Current imprisonment or involuntary incarceration
Data sourced from ClinicalTrials.gov (NCT00654147). 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. Informational only — not medical advice.