A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients

HIV Infections Clinical Trial

Official title:

A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250mg BID) Versus Abacavir (300mg BID) Plus Combivir (3TC 150mg/ZDV 300mg BID) Versus Combivir (3TC 150mg/ZDV 300mg BID) Plus Nelfinavir (1250mg BID) in HIV-1 Infected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005106
• Other study ID #: 264P
• Secondary ID: ESS40002
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2000
• Last updated: June 23, 2005
• Start date: September 1999

Study information

• Verified date: November 2000
• Source: NIH AIDS Clinical Trials Information Service
• 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 look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.

Description:

Patients are randomized to receive stavudine plus lamivudine plus nelfinavir, Combivir (zidovudine plus lamivudine) plus nelfinavir, or Combivir plus abacavir. Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA: (1) greater than 1,000 up to 100,000 copies/ml or (2) greater than 100,000 up to 200,000 copies/ml. Measurements and evaluations for assessment of body fat composition, virologic and immunologic outcomes, markers of alterations in carbohydrate and lipid metabolism, and safety are performed at Baseline, Weeks 4, 8, 16, 24, and every 12 weeks thereafter until Week 96 or withdrawal. In addition, health-related quality of life and health care resource utilization data are collected at specified treatment visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Patients may be eligible for this study if they:

• Are at least 18 years old.

• Are HIV-positive.

• Have a CD4 count greater than 50 cells/mm3.

• Have a viral load greater than 1,000 copies/ml but less than 200,000 copies/ml.

• Have never received anti-HIV medications before. (However, less than 1 week of therapy with lamivudine or a protease inhibitor and less than 4 weeks of therapy with other nucleoside reverse transcriptase inhibitors [NRTIs] is allowed. No therapy with nonnucleoside reverse transcriptase inhibitors [NNRTIs] is allowed.)

• Cannot bear children or agree to use effective methods of birth control during the study. Hormonal methods of birth control (such as birth control pills) are not considered effective for this study.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have an active AIDS-defining opportunistic infection or disease that, in the doctor's opinion, would make them unable to participate.

• Are unable, in the opinion of the doctor, to follow the dosing schedule and follow-up visit schedule.

• Have a substance abuse problem that would interfere with taking the medications correctly or attending the clinic visits.

• Are enrolled in another study.

• Cannot take medications by mouth or absorb drugs.

• Have hepatitis.

• Have a serious medical condition such as diabetes, congestive heart failure, or other heart disease.

• Need chemotherapy or radiation therapy (except for local treatment of Kaposi's sarcoma).

• Are taking certain medications.

• Are pregnant or breast-feeding.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lamivudine/Zidovudine

• Abacavir sulfate

• Nelfinavir mesylate

• Lamivudine

• Stavudine

Locations

Country	Name	City	State
United States	Summa Health System	Akron	Ohio
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	WNC Community Health Services	Asheville	North Carolina
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Philip Brachman	Atlanta	Georgia
United States	Ponce de Leon Ctr	Atlanta	Georgia
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Med Ctr	Boston	Massachusetts
United States	Carolinas Med Ctr	Charlotte	North Carolina
United States	Cook County Hosp	Chicago	Illinois
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Univ of Texas Southwestern Med Ctr	Dallas	Texas
United States	Children's Diagnostic Treatment Ctr	Fort Lauderdale	Florida
United States	Community Health Care	Fort Lauderdale	Florida
United States	Comprehensive Care Center	Fort Lauderdale	Florida
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	Thomas Street Clinic	Houston	Texas
United States	Univ of Missouri at Kansas City School of Medicine	Kansas City	Missouri
United States	Longbeach Memorial Med Ctr	Longbeach	California
United States	AIDS Healthcare Foundation	Los Angeles	California
United States	Good Samaritan Hosp	Los Angeles	California
United States	Maxine Liggins	Los Angeles	California
United States	THE Clinic	Los Angeles	California
United States	UCLA Care Ctr	Los Angeles	California
United States	South Shore Hosp	Miami	Florida
United States	Univ of Miami School of Medicine	Miami	Florida
United States	HIV Outpatient Clinics / LA State Univ Med Ctr	New Orleans	Louisiana
United States	Highland Gen Hosp / San Francisco Gen Hosp	Oakland	California
United States	Orange County Health Dept	Orlando	Florida
United States	MCP Hahnemann Univ Hosp	Philadelphia	Pennsylvania
United States	Immunity Care and Research Inc	Plantation	Florida
United States	Miriam Hosp	Providence	Rhode Island
United States	Univ TX San Antonio Health Science Ctr	San Antonio	Texas
United States	San Francisco Gen Hosp	San Francisco	California
United States	South Jersey Infectious Diseases Inc	Somers Point	New Jersey
United States	Daniel Seekins	Tampa	Florida
United States	Infectious Disease Research Institute	Tampa	Florida
United States	Arizona Clinical Research Ctr Inc	Tucson	Arizona
United States	Georgetown Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,