Immune Reconstitution in naïve HIV Patients With CD4 <100... | NCT00386659

Studies
Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.

NCT00386659

Sponsor

Hospital Clinic of Barcelona

Status

Terminated

Last Update Posted

Oct 11, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

HIV Infection

Interventions

tenofovir + abacavir + lopinavir/ritonavir
tenofovir + abacavir + efavirenz

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

Oct 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 10, 2006

First Submission Date that Met QC Criteria

Oct 10, 2006

First Posted Date

Oct 11, 2006Estimated

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

Oct 10, 2006

Last Update Posted Date

Oct 11, 2006Estimated

Description Module

Brief Summary

Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together with lopinavir or efavirenz.

Detailed Description

Not provided

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months.

Secondary Outcomes

Measure	Description	Time Frame
Degree and kinetics of recovery of the immune system.
New CDC C events
Mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV-infection
Antiretroviral-naive
CD4 cell count below 100 cells/mm3

Exclusion Criteria:

Pregnancy
Current opportunistic infection requiring parenteral therapy
Current malignancies requiring parenteral chemotherapy
Any contraindication to the study 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
Josep M Gatell, MD	Hospital Clinic of Barcelona	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Sant Pau		Barcelona	Barcelona	08025	Spain
Hospital Vall d'Hebron

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

Intervention Browse Module

MeSH Terms

ID	Term
D000068698	Tenofovir
C106538	abacavir
D061466	Lopinavir
D019438	Ritonavir
C098320	efavirenz

Ancestor Terms

ID	Term
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D000225	Adenine

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
tenofovir + abacavir + lopinavir/ritonavir	Drug
tenofovir + abacavir + efavirenz	Drug