A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002410
• Other study ID #: 281B
• Secondary ID: DMP 266-006
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1998
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Lamivudine

• Zidovudine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dupont Merck

Countries where clinical trial is conducted

United States,  Puerto Rico,