Study Stopped
Decision not to go forth with study.
Trial of TDF/FTC + Raltegravir Versus TDF/FTC + Efavirenz in HIV-1-Infected Women
ICE-002
Open Label, Randomized Trial of TDF/FTC+Raltegravir Vs. TDF/FTC+Efavirenz in HIV-1-Infected Women: Differential Effects on Viral Suppression/Reservoir, & Immune Parameters in Different Compartments, Including Gut & Genital Tract
2 other identifiers
interventional
N/A
1 country
5
Brief Summary
Raltegravir not only has a unique mechanism of action, but may also have other unique effects on suppression of viral replication, viral reservoir, and immune reconstitution in blood and other important compartments. This may in part be due to the pharmacokinetics of Raltegravir in blood and gut tissue. Efavirenz will be the comparator antiretroviral drug in this study, with both drugs being used as part of a three-drug regimen with tenofovir and emtricitabine. The primary objectives are to determine differences in the effects of 2 anti-retroviral regimens, Raltegravir + Truvada versus Atripla, with respect to:
- 1.Viral load in plasma, genital tract (vaginal secretions), and gut (by in situ hybridization).
- 2.Latent viral reservoir (pro-viral DNA) in the peripheral blood and genital tract.
- 3.Immune effects (CD4/CD8 immunophenotypes) in gut and PBMCs and plasma cytokine profiles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2011
5 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2009
CompletedFirst Posted
Study publicly available on registry
September 25, 2009
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 6, 2015
May 1, 2015
2 years
May 7, 2009
May 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Viral load in plasma, genital tract (vaginal secretions), and gut (by in situ hybridization)
48 weeks
Latent viral reservoir (pro-viral DNA) in the peripheral blood and genital tract
48 weeks
Immune effects (CD4/CD8 immunophenotypes) in gut and PBMCs and plasma cytokine profiles
48 weeks
Secondary Outcomes (1)
Determine the pharmacokinetics of Raltegravir in blood and gut tissue; relative tissue/compartment penetration compared to Efavirenz
48 weeks
Study Arms (2)
1
ACTIVE COMPARATORTDF/FTC Once-Daily + Raltegravir 400 mg Orally Twice-Daily
2
ACTIVE COMPARATORTDF/FTC + Efavirenz (Atripla) Once-Daily
Interventions
TDF/FTC Once-Daily + Raltegravir 400 mg Orally Twice-Daily
Eligibility Criteria
You may qualify if:
- Eligible subjects will be antiretroviral naïve (\< 7 days of HAART at any time prior to entry) with plasma HIV-1 RNA \> 50,000 copies/mL (obtained within 90 days prior to study entry by any laboratory that has a CLIA certification or its equivalent) and moderate immune suppression within 90 days prior to study entry.
- HIV-1 infected, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test. Alternatively, if a licensed ELISA is not available, two HIV-1 RNA values \>2000 copies/mL at least 24 hours apart performed by any laboratory that has CLIA certification or its equivalent may be used to document infection.
- Female sex, Age \> 18 and \< 60 years, Pre-menopausal.
- Screening CD4+ T-cell count between 200-350 cells/mm3 obtained within 90 days prior to study entry by any laboratory that has a CLIA certification or its equivalent.
- Antiretroviral (ARV) drug-naïve (defined as 7 days of ARV treatment at any time prior to entry).
- Laboratory values obtained within 45 days prior to study entry:
- Absolute neutrophil count (ANC) 500/mm3
- Hemoglobin 8.0 g/dL
- Platelet count 40,000/mm3
- AST (SGOT), ALT (SGPT), and alkaline phosphatase 5 ULN
- Total bilirubin 2.5 x ULN
- Calculated creatinine clearance ≥60 mL/min as estimated by the Cockcroft-Gault equation:
- For women, multiply the result by 0.85 = CrCl (mL/min)
- Negative serum or urine pregnancy test within 48 hours prior to initiating study medications unless otherwise specified by product labeling.
- Female candidates of reproductive potential is defined as women who have had regular menses over the preceding 24 months
- +4 more criteria
You may not qualify if:
- Menopausal (may affect quantity of genital tract secretions) or any serious illness that requires treatment and/or hospitalization until the patient completes therapy
- Any active infection, including co-infection with hepatitis B or C
- Any neoplasm
- Immunosuppressive therapy
- Requirement for any medications that are prohibited by any of the study treatments
- Significant liver or renal dysfunction
- Baseline resistance to any of the study drugs by genotypic testing
- NRTI: M41L, K65 R, D76N, T69D, K70R, L74V/I, y115F, Q151M, M184V, L210W, T215any, K219Q/E
- NNRTI:L100I, K103N, V106A/M, V108I, Y181C/I, Y188C/L/H, G190anyA/S
- Alcohol or substance abuse problems or psychiatric conditions that impair the ability of the subject to comply with the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rush University Medical Centerlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (5)
Mt. Sinai Hospital
Chicago, Illinois, 60608, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
The Ruth M. Rothstein CORE Center (of Cook County)
Chicago, Illinois, 60622, United States
University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan L. Landay, Ph.D.
Rush University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 7, 2009
First Posted
September 25, 2009
Study Start
June 1, 2011
Primary Completion
June 1, 2013
Study Completion
December 1, 2013
Last Updated
May 6, 2015
Record last verified: 2015-05