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NCT00001094 Clinical Trial

A Comparison of Nelfinavir Plus Saquinavir Plus Delavirdine or 3TC/ZDV Versus Nelfinavir Plus 3TC/ZDV in HIV-Infected Patients

HIV Infections Clinical Trial

Official title:
A Phase II, Randomized, Controlled, Open-Label Trial of Combination Therapy With Nelfinavir (NFV) and Saquinavir (SQV)Sgc With Delavirdine (DLV) or 3TC/ZDV Versus Nelfinavir (NFV) and 3TC/ZDV in Subjects With HIV Infection and > 5,000 HIV RNA Copies/ML

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00001094
Other study ID # ACTG 374
Secondary ID
Status Withdrawn
Phase Phase 2
First received November 2, 1999
Last updated March 5, 2015

Study information
Verified date March 2015
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

To compare the long-term virologic response to combination therapy with two protease inhibitors, i.e., nelfinavir (NFV) + saquinavir soft gel capsule (SQVsgc) and delavirdine (DLV) or combination lamivudine/zidovudine (3TC/ZDV, Combivir) versus NFV and 3TC/ZDV, in the proportion of patients demonstrating virologic success (< 500 copies/ml HIV RNA) at week 48, without prior virologic or clinical failure. To evaluate the safety and tolerance of combination protease inhibitors.

To evaluate the durability of virologic response as assessed by the Roche Ultra Sensitive assay (< 200 copies/ml) and culturable virus. To compare time to a confirmed virologic response (two consecutive plasma HIV RNA levels < 500 copies/ml) or to a confirmed treatment relapse following a confirmed virologic response across the treatment arms. To evaluate biologic phenotype (non-syncytium inducing versus syncytium inducing capacity) and the evolution and patterns of viral resistance among patients with confirmed treatment failures at or after weeks 16 to 24. To compare immunologic benefits, as measured by longitudinal CD4/CD8 cell count profiles. To evaluate the influence of baseline virologic and immunologic parameters on the magnitude and duration of plasma HIV RNA response. To compare virologic response between the two dose schedules of NFV and SQVsgc (bid vs tid) and between NFV and SQVsgc with either DLV or combination 3TC/ZDV. To evaluate compliance and exploratory population pharmacometrics.

Past studies have shown that combination therapies not only will result in better clinical outcomes but may prolong the effects of therapy. The enhanced effects seen with combination therapies are likely related to a greater suppression of HIV replication and alterations in resistance patterns. Both in vitro and in vivo studies suggest that triple-drug therapy may have an advantage over one- and two-drug regimens. Therefore, triple-drug therapy appears to be an important strategy in the treatment of HIV infection.

Description:

Past studies have shown that combination therapies not only will result in better clinical outcomes but may prolong the effects of therapy. The enhanced effects seen with combination therapies are likely related to a greater suppression of HIV replication and alterations in resistance patterns. Both in vitro and in vivo studies suggest that triple-drug therapy may have an advantage over one- and two-drug regimens. Therefore, triple-drug therapy appears to be an important strategy in the treatment of HIV infection.

This is a Phase II, randomized, controlled, open-label trial of NFV + SQVsgc and either DLV or combined 3TC/ZDV versus NFV and combined 3TC/ZDV. Prior to randomization, patients are stratified by HIV RNA (above or below 65,000 copies/ml) and by prior antiretroviral therapy (no therapy vs any therapy). Patients (100 patients/arm) are then randomly assigned to one of four arms. Arm I receives NFV plus combination 3TC/ZDV. Arm II receives NFV plus SQVsgc plus combination 3TC/ZDV. Arm III receives NFV plus SQVsgc plus DLV. Arm IV receives NFV plus SQVsgc plus DLV. Treatment continues for 48 weeks following enrollment of the last patient. Response to treatment is assessed at week 16. Patients with confirmed plasma HIV RNA levels >= 500 copies/ml at week 16 whose plasma HIV RNA has decreased since study entry (day 0) may continue therapy and be reassessed at weeks 20 and 24. Patients considered treatment failures (i.e., 2 consecutive plasma HIV RNA levels >= 500 copies/ml at or after week 16) or who have relapsed may register to Step 2 treatment (addition of at least 2 new drugs to their prior treatment regimen), enroll in another ACTG protocol at time of failure, or seek the best available therapy while continuing to be followed for remainder of study.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility This study has been terminated.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lamivudine/Zidovudine

• Nelfinavir mesylate

• Saquinavir

• Delavirdine mesylate

Locations
Country Name City State
Puerto Rico Univ of Puerto Rico San Juan
United States Emory Univ Atlanta Georgia
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Carolinas Med Ctr Charlotte North Carolina
United States Louis A Weiss Memorial Hosp Chicago Illinois
United States Univ of Cincinnati Cincinnati Ohio
United States Ohio State Univ Hosp Clinic Columbus Ohio
United States Univ of Colorado Health Sciences Ctr Denver Colorado
United States Univ of Texas Galveston Galveston Texas
United States Moses H Cone Memorial Hosp Greensboro North Carolina
United States Queens Med Ctr Honolulu Hawaii
United States Univ of Hawaii Honolulu Hawaii
United States Willow Clinic Menlo Park California
United States Univ of Miami School of Medicine Miami Florida
United States Tulane Univ School of Medicine New Orleans Louisiana
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Stanford Univ Med Ctr Stanford California

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

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