NCT00700115

Brief Summary

This study will examine the effectiveness and safety of raltegravir (isentress) when used together with lopinavir/ritonavir (kaletra) for the treatment of HIV-infection. Isentress is a recently, Food and Drug Administration (FDA) approved, HIV medication that has strong effects against the HIV virus. Isentress has been shown in other studies to be safe and well tolerated by HIV patients. Combining this drug with kaletra might enable us to construct a HIV regimen that does not include the more toxic drugs of the nucleoside reverse transcriptase inhibitor class. Eligible volunteers will undergo the following as part of the study procedure:

  1. 1.Sign the study consent form and the HIPAA Authorization Form.
  2. 2.Two-third of subjects, the intervention group (selected by random chance) will have their HIV drug treatment changed to kaletra + isentress.
  3. 3.The other one-third will continue their usual HIV medications (this will be the control group).
  4. 4.Make 9 study related visits to the Ponce clinic during the 48 weeks study period. During these visits, medical information will be collected, and blood tests will be performed.
  5. 5.Perform Dexa-scan on two separate occasions at Emory University Hospital Radiology.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Jun 2008

Typical duration for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

October 22, 2013

Completed
Last Updated

December 12, 2014

Status Verified

November 1, 2014

Enrollment Period

2.6 years

First QC Date

June 16, 2008

Results QC Date

June 7, 2012

Last Update Submit

November 25, 2014

Conditions

HIV Infections

Keywords

HAARTlopinavir/ritonavirraltegravirHIV/AIDS patients on HAARTTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Plasma Viral Loads (HIV-1 RNA PCR)

    Percentage subjects with undetectable Plasma viral loads

    baseline to week 48

Secondary Outcomes (1)

  • To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects

    48 weeks

Study Arms (2)

Kaletra + Isentress

EXPERIMENTAL

Kaletra + Isentress

Drug: Kaletra + Isentress

Standard HAART

ACTIVE COMPARATOR

Pre-study Antiretroviral regimen

Drug: Pre-study antiretroviral regimen

Interventions

Kaletra + IsentressDRUG

Kaletra 400/100 mg + Isentress 400 mg BID

Also known as: Raltegravir, Lopinavir/ritonavir
Kaletra + Isentress
Pre-study antiretroviral regimenDRUG

Standard doses of pre-study antiretroviral regimen

Also known as: HAART
Standard HAART

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-1-infected individuals receiving HAART regimen (if on PI-based regimen, must be 1st PI-containing HAART).
  • They must have been on and tolerating current HAART regimen for \> 6-months.
  • Plasma HIV-1 viral load \< 50 copies/ml at study entry.
  • Men and women age \> 18 years (sex is defined as sex at birth).
  • Laboratory values obtained within 30 days prior to study entry:
  • Hemoglobin \> 9.4 g/dl
  • Creatinine \< 2 mg/dl
  • AST (SGOT) \< 2 x ULN
  • ALT (SGPT) \< 2 x ULN
  • Ability and willingness of subject or legal guardian/representative to give written informed consent.
  • No CD4 T-cell counts requirement

You may not qualify if:

  • Subjects with a history of previous intolerance to or virological failure to LPV/r
  • Concomitant drugs (including alternative therapies) that may affect PI or RAL plasma concentrations (inducers or inhibitors of the CYP 3A4 or UDP-glucuronosyltransferase iso-enzymes).
  • A known history of noncompliance with medications or a known history of noncompliance with scheduled physician and clinic visits.
  • Investigational ARV drug.
  • Pregnancy/Breast feeding.
  • HBV-coinfected patients receiving nucleoside analogue for both HIV and HBV suppression.
  • Active drug or alcohol use or dependence which, in the Investigator's opinion, may interfere with adherence to study requirements or endanger subject's health while on the study.
  • Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to the screening visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Infectious Diseases Program (Ponce Clinic)

Atlanta, Georgia, 30308, United States

Location

Related Publications (1)

  • Ofotokun I, Sheth AN, Sanford SE, Easley KA, Shenvi N, White K, Eaton ME, Del Rio C, Lennox JL. A switch in therapy to a reverse transcriptase inhibitor sparing combination of lopinavir/ritonavir and raltegravir in virologically suppressed HIV-infected patients: a pilot randomized trial to assess efficacy and safety profile: the KITE study. AIDS Res Hum Retroviruses. 2012 Oct;28(10):1196-206. doi: 10.1089/AID.2011.0336. Epub 2012 Apr 20.

    PMID: 22364141RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

lopinavir-ritonavir drug combinationRaltegravir PotassiumLopinavirAntiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesDrug Therapy, CombinationDrug TherapyTherapeutics

Limitations and Caveats

The findings of the KITE study should be interpreted in the context of a pilot study with a small sample size. Furthermore, adverse effects were self-reported, and the lack of blinding may have introduced biases in the collection of the data.

Results Point of Contact

Title
Dr. Igho Ofotokun
Organization
Emory University School of Medicine
iofotok@emory.edu
404-616-0659

Study Officials

  • Igho Ofotokun, MD, MSc

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 16, 2008

First Posted

June 18, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

December 12, 2014

Results First Posted

October 22, 2013

Record last verified: 2014-11

Locations

US(1)