Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00002220

Collaborator

(none)

120

Enrollment

Locations

10.9

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Indinavir sulfate Drug: Efavirenz Drug: Levocarnitine Drug: Adefovir dipivoxil	Phase 3

Detailed Description

In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Multi-Center, Open-Label Study of the Effect of Indinavir, Efavirenz, and Adefovir Dipivoxil Combination Therapy in Patients Who Have Failed Nelfinavir

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients must have:

Serologically documented HIV infection.
Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml.
Parental consent for patients under 18.

Nelfinavir-Failure Group:

Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent.
Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold).

Control Group:

Must have received any combination of currently licensed nucleoside reverse transcriptase inhibitors for at least 16 weeks.
Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's.

Exclusion Criteria

Prior Medication:

Excluded:

Control group:

Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors.

Required:

Nelfinavir-failure patients:

At least 16 weeks of nelfinavir.

Control group:

At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LAC / USC Med Ctr / Infectious Diseases	Los Angeles	California	United States	90033
2	Yale Univ / AIDS Clinical Trials Unit	New Haven	Connecticut	United States	06510
3	Med Ctr of Delaware	Wilmington	Delaware	United States	19899
4	Hawaii AIDS Clinical Trial Unit	Honolulu	Hawaii	United States	96816
5	Rush Presbyterian Saint Lukes Med Ctr	Chicago	Illinois	United States	606123832
6	Johns Hopkins Hosp	Baltimore	Maryland	United States	212876220
7	Massachusetts Gen Hosp	Boston	Massachusetts	United States	02114
8	Columbia Presbyterian Hosp	New York	New York	United States	10032
9	AIDS TMT Unit / Univ Hosp	Stonybrook	New York	United States	117948153
10	Vanderbilt Clinic	Nashville	Tennessee	United States	37212
11	Oaklawn Physicians Group	Dallas	Texas	United States	75219