Clinical trial NCT00002220: Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir
Official title: Multi-Center, Open-Label Study of the Effect of Indinavir, Efavirenz, and Adefovir Dipivoxil Combination Therapy in Patients Who Have Failed Nelfinavir
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Resistance
Drug Therapy, Combination
Antiviral Agents
HIV Protease Inhibitors
Indinavir
RNA, Viral
Adenine
efavirenz
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LAC / USC Med Ctr / Infectious Diseases
state: California
city: New Haven
country: United States
facility: Yale Univ / AIDS Clinical Trials Unit
state: Connecticut
city: Wilmington
country: United States
facility: Med Ctr of Delaware
state: Delaware
city: Honolulu
country: United States
facility: Hawaii AIDS Clinical Trial Unit
state: Hawaii
city: Chicago
country: United States
facility: Rush Presbyterian Saint Lukes Med Ctr
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: Boston
country: United States
facility: Massachusetts Gen Hosp
state: Massachusetts
city: New York
country: United States
facility: Columbia Presbyterian Hosp
state: New York
city: Stonybrook
country: United States
facility: AIDS TMT Unit / Univ Hosp
state: New York
city: Nashville
country: United States
facility: Vanderbilt Clinic
state: Tennessee
city: Dallas
country: United States
facility: Oaklawn Physicians Group
state: Texas
Study officials:
References: