Clinical trial NCT00005106: A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Zidovudine
Stavudine
HIV Protease Inhibitors
Lamivudine
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Adipose Tissue
Lipodystrophy
abacavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

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