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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2002 by NIH AIDS Clinical Trials Information Service.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00005000

First received: March 21, 2000

Last updated: June 23, 2005

Last verified: July 2002

History of Changes

Tracking Information
First Received Date ^ICMJE	March 21, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	December 1999
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00005000 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Treatment With Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
Official Title ^ICMJE	A Randomized, Open-Label, Study of Nelfinavir or Efavirenz in HIV-1 Infected, Antiretroviral Naive Patients
Brief Summary	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	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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Intervention Model: Crossover Assignment Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Nelfinavir mesylate Drug: Efavirenz Drug: Lamivudine Drug: Keyhole-Limpet Hemocyanin Drug: Stavudine Drug: Zidovudine Drug: Didanosine
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	200
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00005000
Other Study ID Numbers ^ICMJE	259H, AG1343-1127
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Agouron Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	July 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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