Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients

NCT ID: NCT00038220

Last Updated: 2006-07-27

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Brief Summary

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The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the growth of HIV in patients infected with the virus.

Detailed Description

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Conditions

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HIV Infections

Keywords

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lopinavir/ritonavir

Intervention Type DRUG

Efavirenz

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Tenofovir DF

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have HIV Infection.
* Age 18 to 65 years old.
* Show no signs of recent illness other than HIV infection.
* Agree to use a barrier method of birth control during the study and for 30 days after study.

Exclusion Criteria

* Are unable to follow study requirements (in the opinion of the investigator).
* Are pregnant or breast-feeding.
* Are unable to take medications by mouth.
* Have chronic nausea or vomiting.
* Have cancer other than Kaposi's sarcoma or basal cell carcinoma.
* Have active, serious infections (other than HIV) requiring antibiotic injections within 15 days prior to screening.
* Are taking any medications that are not allowed with ABT-378/r and efavirenz.
* Are taking or have taken any other experimental drugs, antiretroviral drugs, or drugs that affect the immune system within 30 days of start of study without consent of the medical monitor.
* Are receiving or have received radiation therapy within 30 days of start of study without consent of the medical monitor.
* Have a history of drug abuse or mental illness that would prevent the patient from following the protocol requirements.
* Have a history of kidney or bone disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

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Scott Brun, M.D.

Role: STUDY_DIRECTOR

Head, Antiviral Global Project Team

Locations

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Aaron Diamond AIDS Research Center - Rockefeller University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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M00-154

Identifier Type: -

Identifier Source: org_study_id

NCT00006189

Identifier Type: -

Identifier Source: nct_alias