Pilot Assessment of Lopinavir/Ritonavir and Maraviroc | NCT00981318

Studies
Pilot Assessment of Lopinavir/Ritonavir and Maraviroc

NCT00981318

Sponsor

Rodwick, Barry M., M.D.

Status

Terminated

Last Update Posted

Jun 23, 2015Estimated

Enrollment

3Actual

Phase

Phase 4

Conditions

HIV Infections
Acquired Immunodeficiency Syndrome

Interventions

lopinavir/ritonavir plus maraviroc

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

unable to enroll expected number of subjects

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Sep 19, 2009

First Submission Date that Met QC Criteria

Sep 21, 2009

First Posted Date

Sep 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2015

Last Update Posted Date

Jun 23, 2015Estimated

Name	Class
Abbott	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

As long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. This study is to assess the response of one such "nucleoside-sparing" therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid	Other	single arm	Drug: lopinavir/ritonavir plus maraviroc

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lopinavir/ritonavir plus maraviroc	Drug	lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid	lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Virologic response defined as viral load reduction of >/= 1 log		48 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barry M. Rodwick, M. D.	Barry M. Rodwick, M. D.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barry M. Rodwick, M. D.		Safety Harbor	Florida	34695	United States

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061466	Lopinavir
D019438	Ritonavir
D000077592	Maraviroc
C558899	lopinavir-ritonavir drug combination

Ancestor Terms

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided