A Randomized Trial of the Efficacy and Safety of a Strategy of Starting With Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals With CD4+ Cell Counts Less Than or Equal to 200/mm3

NCT00000859 | Completed

• 2 other identifiers: CPCRA 04211592
• Study Type: interventional
• Target: 1,300
• Locations: 2 countries
• Sites: 44

Brief Summary

To compare nelfinavir (NFV) with ritonavir (RTV) for delaying disease progression or death in HIV-infected patients with CD4+ cell counts less than 100 cells/mm3 \[AS PER AMENDMENT 3/11/98: less than or equal to 200 cells/mm3\]. To compare NFV with RTV for the development of adverse events and for rates of permanent discontinuation of study medication. \[AS PER AMENDMENT 10/02/97: To compare by intention-to-treat analysis for disease progression, including death, the following two regimens: NFV plus background combination antiretroviral (AR) therapy followed by indinavir (IDV) or RTV in the event of significant intolerance; and RTV plus AR therapy followed by IDV, then NFV, in the event of significant intolerance.\] \[AS PER AMENDMENT 3/11/98: SUBSTUDY CPCRA 045: To determine the relative rates of emergence of HIV-1 resistance and to compare changes in plasma HIV RNA levels and CD4+ cell counts in a sample of patients with CD4+ cell counts \<= 200/mm3 who are enrolled in protocol CPCRA 042.\] AR therapy is rapidly becoming the standard of care for the treatment of HIV infection. AR therapy provides the best opportunity for maximizing viral suppression, reducing toxicity and delaying the emergence of resistant strains. The newest class of AR agents, the HIV protease inhibitors, exhibits the most potent anti-HIV effects described to date. This study will compare 2 protease inhibitors, NFV and RTV for efficacy and safety in a population with advanced HIV disease, who are taking various background nucleoside therapies.

Conditions

HIV Infections

Keywords

HIV-1; Drug Resistance; Drug Therapy, Combination; HIV Protease Inhibitors; CD4 Lymphocyte Count; Ritonavir; Indinavir; Disease Progression; RNA, Viral; Genotype; Nelfinavir; Anti-HIV Agents; Viral Load

Interventions

Indinavir sulfate DRUG

Ritonavir DRUG

Nelfinavir mesylate DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Background AR nucleoside therapy is required, although background AR therapy may also be no background therapy. However, the use of protease inhibitors is not recommended as monotherapy unless there is no other alternative. Therefore, patients who are not on AR treatment may be enrolled at the discretion of the clinician.
• Allowed:
• Saquinavir.
• Patients must have:
• Documented HIV infection.
• A CD4+ cell count \<= 100/mm3 within 3 months prior to the study. \[AS PER AMENDMENT 3/11/98: CD4+ cell count \<= 200/mm3 any time prior to entry\].
• Parental consent if patient is \< 18 years old.
• Prior Medication:
• Allowed:
• Saquinavir (SQV).

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Stage 2 or greater AIDS dementia complex.
• \[AS PER AMENDMENT 10/2/97: Any acute disease or condition that would, in the physician's judgement, contraindicate starting NFV or RTV.\]
• Known hypersensitivity to RTV or any of its ingredients (for patients assigned to RTV therapy).
• Concurrent Medication:
• Excluded:
• Concomitant use of protease inhibitors.
• Concomitant treatments that cannot be discontinued, and in the physician's judgement, should not be taken with NFV or RTV.
• AS PER AMENDMENT 10/2/97:
• For patients randomized to NFV:
• Concomitant therapy with terfenadine, astemizole, cisapride, triazolam, midazolam, ergot derivatives, amiodarone, quinidine, or rifampin.
• For patients randomized to IDV:
• Concomitant therapy with terfenadine, astemizole, cisapride, triazolam, midazolam, and rifampin.
• Patients with any of the following prior symptoms are excluded:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (44)

Community Consortium / UCSF

San Francisco, California, 94110, United States

Location

Community Consortium of San Francisco

San Francisco, California, 94110, United States

Location

Denver Community Program for Clinical Research on AIDS

Denver, Colorado, 80204, United States

Location

Denver CPCRA / Denver Pub Hlth / Rocky Mt Cancer Ctr Aurora

Denver, Colorado, 80204, United States

Location

Denver CPCRA / Denver Public Hlth

Denver, Colorado, 80204, United States

Location

Infectious Disease Physicians / Northern Virginia

Washington D.C., District of Columbia, 20422, United States

Location

Timothy A Price

Washington D.C., District of Columbia, 20422, United States

Location

Veterans Administration Med Ctr / Regional AIDS Program

Washington D.C., District of Columbia, 20422, United States

Location

Washington Reg AIDS Prog / Dept of Infect Dis

Washington D.C., District of Columbia, 20422, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

AIDS Research Alliance - Chicago

Chicago, Illinois, 60657, United States

Location

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, 70112, United States

Location

Louisiana Community AIDS Research Program

New Orleans, Louisiana, 70112, United States

Location

Baltimore TRIALS

Baltimore, Maryland, 21201, United States

Location

Westat / NICHD

Rockville, Maryland, 20850, United States

Location

Comprehensive AIDS Alliance of Detroit

Detroit, Michigan, 48201, United States

Location

Wayne State Univ / Univ Hlth Ctr

Detroit, Michigan, 48201, United States

Location

Henry Ford Hosp

Detroit, Michigan, 48202, United States

Location

Mercer Area Early Intervention Services

Camden, New Jersey, 08103, United States

Location

Southern New Jersey AIDS Clinical Trials

Camden, New Jersey, 08103, United States

Location

Southern New Jersey AIDS Cln Trials / Dept of Med

Camden, New Jersey, 08103, United States

Location

New Jersey Community Research Initiative

Newark, New Jersey, 07103, United States

Location

North Jersey Community Research Initiative

Newark, New Jersey, 07103, United States

Location

Partners in Research - New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Partners Research

Albuquerque, New Mexico, 87131, United States

Location

Harlem AIDS Treatment Group / Harlem Hosp Ctr

New York, New York, 10037, United States

Location

Harlem AIDS Treatment Group

New York, New York, 10037, United States

Location

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, 97210, United States

Location

The Research and Education Group

Portland, Oregon, 97210, United States

Location

Philadelphia FIGHT

Philadelphia, Pennsylvania, 19107, United States

Location

Saint Joseph's Hosp

Philadelphia, Pennsylvania, 19107, United States

Location

Richmond AIDS Consortium

Richmond, Virginia, 23298, United States

Location

Saint Paul's Hosp

Vancouver, British Columbia, Canada

Location

QEII Health Science Centre

Halifax, Nova Scotia, Canada

Location

Saint Joseph's Hosp

London, Ontario, Canada

Location

Ottawa Gen Hosp

Ottawa, Ontario, Canada

Location

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Location

Toronto Gen Hosp

Toronto, Ontario, Canada

Location

Wellesley Hosp

Toronto, Ontario, Canada

Location

Hotel - Dieu de Montreal

Montreal, Quebec, Canada

Location

Montreal Chest Institute

Montreal, Quebec, Canada

Location

SMBD-Jewish Gen Hosp

Montreal, Quebec, Canada

Location

Centre De Recherche En Infectiologie

Ste-Foy, Quebec, Canada

Location

Royal Univ Hosp

Saskatoon, Saskatchewan, Canada

Location

Related Publications (3)

• MacArthur RD, Perez G, Walmsley S, Baxter J, Neaton J, Wentworth D. CD4 cell count is a better predictor of disease progression than HIV RNA level in persons with advanced HIV infection on highly active antiretroviral therapy. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 203)

  BACKGROUND

• Perez G, MacArthur RD, Walmsley S, Baxter JA, Mullin C, Neaton JD; Terry Beirn Community Programs for Clinical Research on AIDS; Canadian Trials Network. A randomized clinical trial comparing nelfinavir and ritonavir in patients with advanced HIV disease (CPCRA 042/CTN 102). HIV Clin Trials. 2004 Jan-Feb;5(1):7-18. doi: 10.1310/N11F-NK93-MUMR-A1VV.

  PMID: 15002082 RESULT

• MacArthur RD, Perez G, Walmsley S, Baxter JD, Mullin CM, Neaton JD; Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) 042/045; Canadian HIV Trials Network (CTN) 102 Protocol Teams. Comparison of prognostic importance of latest CD4+ cell count and HIV RNA levels in patients with advanced HIV infection on highly active antiretroviral therapy. HIV Clin Trials. 2005 May-Jun;6(3):127-35. doi: 10.1310/A9B9-RQD7-U8KA-503U.

  PMID: 16192247 RESULT

MeSH Terms

Conditions

HIV Infections; Disease Progression

Interventions

Indinavir; Ritonavir; Nelfinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Perez G

  STUDY CHAIR

• MacArthur R

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: December 1, 2001
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

CA (12); US (32)