HIV-1 Viral Dynamics in Subjects Initiating Raltegravir T... | NCT00685191

Studies
HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain

NCT00685191

Sponsor

Germans Trias i Pujol Hospital

Status

Completed

Last Update Posted

Dec 4, 2019Actual

Enrollment

15Actual

Phase

Phase 4

Conditions

HIV Infections

Interventions

Salvage antiretroviral therapy including raltegravir

Countries

Spain

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

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Apr 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

May 23, 2008

First Submission Date that Met QC Criteria

May 27, 2008

First Posted Date

May 28, 2008Estimated

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

Dec 3, 2019

Last Update Posted Date

Dec 4, 2019Actual

Name	Class
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	OTHER

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

The study purpose is to investigate plasma HIV-1 RNA dynamics in subjects initiating raltegravir-based salvage therapy and quantify the corresponding changes in levels of cellular HIV-1 DNA.

Detailed Description

First- and second-phase decay rates of plasma HIV-1 RNA and changes in the intracellular levels of HIV-1 proviral DNA and LTR circles will be measured in subjects starting salvage antiretroviral therapy including raltegravir in Spain.

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	HIV-1-infected subjects initiating raltegravir-including salvage therapy	Drug: Salvage antiretroviral therapy including raltegravir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Salvage antiretroviral therapy including raltegravir	Drug	Initiation of raltegravir-including salvage antiretroviral therapy	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in viral load from day 0 to 7		1 week

Secondary Outcomes

Measure	Description	Time Frame
Intracellular levels of HIV-1 proviral DNA and LTR circles		24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have limited or no treatment options due to extensive antiretroviral drug resistance or drug intolerance.
Subjects initiating raltegravir plus another fully active antiretroviral drug.

Exclusion Criteria:

Pregnancy, or fertile women willing to be pregnant.
Active substance abuse or major psychiatric 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
Bonaventura Clotet, MD,PhD	Hospital U. Germans Trias i Pujol	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital U. Germans Trias i Pujol		Badalona	Barcelona	08916	Spain

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

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