Clinical trial NCT00002410: A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients
Official title: A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
Zidovudine
Drug Resistance, Microbial
HIV Protease Inhibitors
Lamivudine
Indinavir
Genotype
Reverse Transcriptase Inhibitors
efavirenz
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266 plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study also examines the resistance HIV may have to these drugs and if these drugs are effective over a long period of time.


Eligibility criteria: Exclusion Criteria

Concurrent Medication:

Excluded:

* Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 \[CYP3A4\] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events \[i.e., cardiac arrhythmia, prolonged sedation\]).
* Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir).
* Ketoconazole, itraconazole, and clarithromycin.
* Concomitant systemic therapy for acute opportunistic infection or malignancy.

Excluded:

Life expectancy less than 12 months.

Prior Medication:

Excluded:

* Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor.
* Prior antiretroviral agent within 14 days of initiating study treatment.
* Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication.

Patients must:

* Have a diagnosis of HIV infection.
* Have CD4 counts greater than or equal to 50 cell/mm3.
* Have a life expectancy greater than or equal to 12 months.
* Be post-pubescent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Body Positive
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Ctr Inc
state: Arizona
city: Beverly Hills
country: United States
facility: Richard Stryker
state: California
city: Irvine
country: United States
facility: Paul Cimoch
state: California
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: Los Angeles
country: United States
facility: Kraus Med Group
state: California
city: Los Angeles
country: United States
facility: Oasis Clinic / Martin Luther Jr Gen Hosp / King-Drew Med Ctr
state: California
city: Stamford
country: United States
facility: Blick Med Associates
state: Connecticut
city: Washington
country: United States
facility: Novum Inc
state: District of Columbia
city: Bradenton
country: United States
facility: Bach and Godofsky
state: Florida
city: Coral Gables
country: United States
facility: Community Research Initiative of South Florida
state: Florida
city: Jacksonville
country: United States
facility: Boulevard Comprehensive Care Ctr
state: Florida
city: Lake Worth
country: United States
facility: Larry Marc Bush / c/o Sally Yantis
state: Florida
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Tampa
country: United States
facility: Ctr for Quality Care
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: Vero Beach
country: United States
facility: Treasure Coast Infectious Disease Consultants
state: Florida
city: Atlanta
country: United States
facility: Georgia Research Associates
state: Georgia
city: Augusta
country: United States
facility: Med College of Georgia
state: Georgia
city: Indianapolis
country: United States
facility: Infectious Diseases
state: Indiana
city: Lexington
country: United States
facility: Univ of Kentucky Med Ctr
state: Kentucky
city: Kansas City
country: United States
facility: Kansas City AIDS Research Consortium
state: Missouri
city: Omaha
country: United States
facility: Univ of Nebraska Med Ctr / HIV Clinic
state: Nebraska
city: Las Vegas
country: United States
facility: Univ Med Ctr / HIV Wellness Ctr
state: Nevada
city: New York
country: United States
facility: Community Research Initiative on AIDS
state: New York
city: New York
country: United States
facility: Clinical Directors Network / HIV/AIDS Program Manager
state: New York
city: Winston Salem
country: United States
facility: Wake Forest Univ School of Medicine
state: North Carolina
city: Columbus
country: United States
facility: Remington-Davis Inc
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hosp
state: Rhode Island
city: Dallas
country: United States
facility: Research Services 2000 Inc
state: Texas
city: Dallas
country: United States
facility: Division of Infectious Disease / Dept of Internal Medicine
state: Texas
city: Fort Worth
country: United States
facility: Research Services 2000 Inc
state: Texas
city: Houston
country: United States
facility: Montrose Clinic
state: Texas
city: Houston
country: United States
facility: UT-Health Science Ctr
state: Texas
city: San Antonio
country: United States
facility: Diagnostic Clinic of San Antonio
state: Texas
city: Newport News
country: United States
facility: Oyster Point Med Specialists
state: Virginia
city: Seattle
country: United States
facility: Novum Inc / Pharmaceutical Research Services
state: Washington
city: Milwaukee
country: United States
facility: Infectious Diseases Associates
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Javier O Morales Ramirez
Study officials:
References: