Brief Summary

This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline

Completed

Started Dec 2009

Longer than P75 for phase_4 hiv-infections

Geographic Reach

1 country

1 active site

Status

terminated

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

5.4 years study duration

First Submitted

Initial submission to the registry

September 19, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed

2 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed

5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed

Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

5.4 years

First QC Date

September 19, 2009

Last Update Submit

June 20, 2015

Conditions

HIV Infections Acquired Immunodeficiency Syndrome

Keywords

Acquired Immunodeficiency SyndromeHIVAIDStreatment experienced

Outcome Measures

Primary Outcomes (1)

Virologic response defined as viral load reduction of >/= 1 log
48 weeks

Secondary Outcomes (6)

Assess proportion of patients with HIV-1 viral load < 48 copies
48 weks
Assess time to loss of virologic response
48 weeks
Assess development of resistance mutations in patients who develop rebound
48 weeks
Compare serum lipid profile changes
48 weeks
Assess safety and tolerability
48 weeks
+1 more secondary outcomes

Study Arms (1)

lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid

OTHER

single arm

Drug: lopinavir/ritonavir plus maraviroc

Interventions

lopinavir/ritonavir plus maravirocDRUG

lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid

Also known as: Kaletra, lopinavir, Selzentry

lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

HIV viral load \> 1,000 on current antiviral medications
No resistance to study medications
Over 18 years of age

You may not qualify if:

Hepatitis B co-infection
Pregnancy
Previous therapy with either of the study medications
Ongoing substance abuse
Significant history of other physical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Rodwick, Barry M., M.D.lead
Abbottcollaborator

Study Sites (1)

Barry M. Rodwick, M. D.

Safety Harbor, Florida, 34695, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

LopinavirRitonavirMaraviroclopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzolesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsTriazoles

Study Officials

Barry M. Rodwick, M. D.
Barry M. Rodwick, M. D.
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDIV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

September 19, 2009

First Posted

September 22, 2009

Study Start

December 1, 2009

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

US(1)

Study Stopped

Pilot Assessment of Lopinavir/Ritonavir and Maraviroc

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations