A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1

NCT ID: NCT00100984

Last Updated: 2017-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-21

Study Completion Date

2005-07-16

Brief Summary

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The main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected.

Detailed Description

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Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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FUZEON [enfuvirtide]

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* CD4 cell count greater than 50 cells/mm\^3
* HIV-1 RNA viral load greater than or equal to 5000 copies/mL
* Patients must be HIV treatment experienced
* Patients diagnosed with HIV-1 infection

Exclusion Criteria

* Female patients must not be able to have children or must be under effective contraceptives
* Female patients who are pregnant
* Have taken enfuvirtide and/or T-1249 before
* Have serious kidney problems
* Alcohol and/or drug abuse
* Have had an organ transplant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hobson City, Alabama, United States

Site Status

Los Angeles, California, United States

Site Status

Los Angeles, California, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Orlando, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Macon, Georgia, United States

Site Status

Chicago, Illinois, United States

Site Status

Chicago, Illinois, United States

Site Status

Baltimore, Maryland, United States

Site Status

Boston, Massachusetts, United States

Site Status

Jackson, Mississippi, United States

Site Status

St Louis, Missouri, United States

Site Status

Newark, New Jersey, United States

Site Status

New York, New York, United States

Site Status

New York, New York, United States

Site Status

Huntersville, North Carolina, United States

Site Status

Dallas, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ML18021

Identifier Type: -

Identifier Source: org_study_id

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