Sequential HIV Therapy in Treatment Resistant HIV-1 Infec... | NCT00128908

Studies
Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients

NCT00128908

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Terminated

Last Update Posted

Sep 15, 2009Estimated

Enrollment

3Actual

Phase

Phase 4

Conditions

HIV Infections

Interventions

Standard Continuous Highly Active Antiretroviral Therapy (HAART)
Rapidly Cycled HAART

Countries

Netherlands

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

ID	Type	Description	Link
2004040 - Dutch AIDS Fund

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Did not recruit

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Jan 2007Actual

Completion Date

Jan 2007Actual

First Submitted Date

Aug 8, 2005

First Submission Date that Met QC Criteria

Aug 8, 2005

First Posted Date

Aug 10, 2005Estimated

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

Sep 14, 2009

Last Update Posted Date

Sep 15, 2009Estimated

Name	Class
Dutch AIDS Fund	UNKNOWN

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 an open label, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy.

Detailed Description

Mathematical modeling has suggested that cyclic use of antiretroviral therapy can be an effective strategy in lowering viral load in HIV-1 infected patients when regular triple drug combinations have lost efficacy due to the emergence of HIV resistance mutations.

The objectives are to study the feasibility, safety and efficacy of sequential combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral agents and who currently have no adequate treatment options available.

This is an open-label, crossover, pilot study. Patients that fail their current regimen, and who currently have no adequate treatment options left, will be randomized to start either an alternating triple combination, or to start a continuous quadruple regimen of drugs. After 6 weeks, patients will crossover from either strategy to the other strategy for another 6 weeks. Each period is preceded by an interruption of all antiretroviral therapy for 4 weeks. In the study period when regimens are alternated, two combinations of three drugs with the least possible cross-resistance will alternate every week.

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
Continuous triple-class therapy	Active Comparator	Patients will be treated with a regimen containing antiretroviral agents from 3 different classes	Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART)
Alternating therapy	Experimental	Patients will be assigned to weekly alternating dual-class regimen	Drug: Rapidly Cycled HAART

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard Continuous Highly Active Antiretroviral Therapy (HAART)	Drug		Continuous triple-class therapy
Rapidly Cycled HAART

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in plasma HIV-1 RNA load		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in the genotype of the dominant quasispecies		12 weeks
Replicative fitness of the dominant quasispecies		12 weeks
Changes in CD4+ and CD8+ cell counts

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV-1 infected patients
At least 18 years of age
Males or non-pregnant, non-lactating females
Documented virological treatment failure on at least 3 classes of antiretroviral drugs
No adequate antiretroviral therapy possible with currently available antiretroviral agents
Virological treatment failure is defined as plasma HIV-1 RNA levels > 5000 while taking at least three different antiretroviral drugs

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
Joep MA Lange, MD PhD	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Study Chair
Ferdinand Wit, MD PhD	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HIV Outpatient Clinic, Academic Medical Center		Amsterdam	North Holland	1105AZ	Netherlands

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

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