Clinical trial NCT00002411: A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs
Official title: A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV-1
Didanosine
Drug Therapy, Combination
Zidovudine
Stavudine
Lamivudine
RNA, Viral
Nelfinavir
Anti-HIV Agents
Viral Load
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety of didanosine plus stavudine plus nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines how long these drug combinations are effective in lowering viral load (level of HIV in the blood).


Eligibility criteria: Inclusion Criteria

Patients must have:

Within 15 business days prior to randomization:

* CD4 cell count greater than or equal to 100 cells/mm3.
* HIV RNA greater than or equal to 2,000 copies/ml by Roche Amplicor Assay.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

* Bilateral peripheral neuropathy.
* Intractable diarrhea.
* Proven or suspected acute hepatitis within 30 days prior to study entry.

Concurrent Medication:

Excluded:

- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.

Concurrent Treatment:

Excluded:

Therapy for any co-existing disease that may interfere with patient ability to participate in this study.

Patients with the following prior conditions are excluded:

History of acute or chronic pancreatitis.

Prior Medication:

Excluded:

* Therapy for any previous disease that may interfere with patient ability to participate in this study.
* Excluded within 14 days prior to randomization:

Greater than 4 weeks of nucleoside therapy or greater than 1 week of protease inhibitor therapy.

* Excluded within 3 months of the start of this study or expected need at time of enrollment:
* Agents with significant systemic myelosuppressive, neurotoxic, pancreatoxic, hepatotoxic, or cytotoxic potential.
* Inability to tolerate oral medication.

Prior Treatment:

Excluded:

Therapy for any previous disease that may interfere with patient ability to participate in this study.

Risk Behavior:

Excluded:

Active alcohol or substance abuse that, in the opinion of the investigator, is sufficient to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sorra Research Ctr / Med Forum
state: Alabama
city: Phoenix
country: United States
facility: Body Positive
state: Arizona
city: Fresno
country: United States
facility: Hill Top Research Inc
state: California
city: Los Angeles
country: United States
facility: UCLA Med Ctr / CARE BH-412 CHS
state: California
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: Los Angeles
country: United States
facility: West Los Angeles VAMC
state: California
city: Sherman Oaks
country: United States
facility: Sherman Oaks Hosp Research Institute
state: California
city: Torrance
country: United States
facility: Harbor UCLA Med Ctr / Research and Educational Institute
state: California
city: New Haven
country: United States
facility: Yale New Haven Hosp / Nathan Smith Clinic
state: Connecticut
city: Washington
country: United States
facility: GW Med Ctr / Clinical Trials Unit
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Med Alternatives
state: Florida
city: Fort Lauderdale
country: United States
facility: Urgent Care Ctr
state: Florida
city: Miami
country: United States
facility: Specialty Med Care Ctrs of South Florida Inc
state: Florida
city: Tampa
country: United States
facility: Hillsborough County Health Dept
state: Florida
city: Tampa
country: United States
facility: Saint Josephs Hosp
state: Florida
city: Chicago
country: United States
facility: Northwestern Univ / Div of Infect Diseases
state: Illinois
city: Chicago
country: United States
facility: Rush Presbyterian / ST Lukes Med Ctr
state: Illinois
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine / Office of Rsch
state: Kansas
city: Lexington
country: United States
facility: Ky Clinic Annex #4 / Room 205E / Speed Sort #0284
state: Kentucky
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Med Ctr
state: New Hampshire
city: Newark
country: United States
facility: NJCRI
state: New Jersey
city: Somerville
country: United States
facility: Infectious Disease Assoc of Central Jersey
state: New Jersey
city: Farmingdale
country: United States
facility: UCT International
state: New York
city: New York
country: United States
facility: St Luke Roosevelt Hosp
state: New York
city: Rochester
country: United States
facility: St Mary's Hosp (Univ of Rochester/Infectious Diseases)
state: New York
city: Stony Brook
country: United States
facility: SUNY at Stony Brook / Div of Infectious Disease
state: New York
city: Charlotte
country: United States
facility: Nalle Clinic / Clinical Research Dept
state: North Carolina
city: Tulsa
country: United States
facility: Associates in Med and Mental Health
state: Oklahoma
city: Philadelphia
country: United States
facility: Stephen P Hauptman
state: Pennsylvania
city: Charleston
country: United States
facility: Med Univ of South Carolina / Div of Infect Disease
state: South Carolina
city: Galveston
country: United States
facility: Univ of Texas / Med Branch at Galveston
state: Texas
city: Houston
country: United States
facility: Joseph C Gathe
state: Texas
Study officials:
References: