A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs

HIV Infections Clinical Trial

Official title:

A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002411
• Other study ID #: 039E
• Secondary ID: AI454-148
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: April 13, 2011
• Start date: March 1998
• Est. completion date: September 1999

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 1999
• Est. primary completion date: September 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Nelfinavir mesylate

• Lamivudine

• Stavudine

• Zidovudine

• Didanosine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm