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Treatment With Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

NCT ID: NCT00005000

Last Updated: 2005-06-24

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Brief Summary

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The purpose of this study is to compare two drugs (nelfinavir \[NFV\] and efavirenz \[EFV\]) used in start-up anti-HIV treatment. Doctors want to see if one is better than the other in extending the time that viral load (level of HIV in the blood) is kept low. The study will also look at the response of the immune system to each drug.

Detailed Description

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Patients are randomized to initiate therapy and receive either nelfinavir (NFV) or efavirenz (EFV) in the first regimen (R1). All patients also receive zidovudine (AZT) and lamivudine (3TC). Patients are further randomized in a factorial fashion and by stratification based on HIV RNA level (less than 10,000, 10,000-100,000, or greater than 100,000 copies/ml) to be administered a single injection of a neo-antigen (KLH) at Week 12, 24, or 48. Therapy continues until switch criteria are met either before or after Week 24. When switch criteria are met, patients advance to the next regimen (R2).

R2 patients previously taking NFV switch to EFV; those randomized to EFV switch to NFV; the additional NRTIs change to stavudine (d4T) and didanosine (ddI). Therapy is continued for an additional 24 weeks.

Conditions

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HIV Infections

Keywords

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HIV-1 Drug Therapy, Combination Lymphoid Tissue HIV Protease Inhibitors Genotype Phenotype Nelfinavir Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Adipose Tissue Glucose Lipids Immunophenotyping efavirenz

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Interventions

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Nelfinavir mesylate

Intervention Type DRUG

Efavirenz

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Keyhole-Limpet Hemocyanin

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Didanosine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients may be eligible for this trial if they:

* Are HIV-positive.
* Have a CD4 count of at least 100 cells/mm3.
* Have a viral load of at least 5,000 copies/ml.

Exclusion Criteria

Patients may not be eligible for this study if they:

* Have taken any antiretroviral (anti-HIV) agent.
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agouron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Agouron Pharmaceuticals Inc

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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AG1343-1127

Identifier Type: -

Identifier Source: secondary_id

259H

Identifier Type: -

Identifier Source: org_study_id