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

NCT00001094 | Withdrawn Phase 2

• 1 other identifier: ACTG 374
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 17

Brief 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.

Conditions

HIV Infections

Keywords

HIV-1; Drug Therapy, Combination; Zidovudine; Lamivudine; RNA, Viral; Saquinavir; Delavirdine; Anti-HIV Agents; Nelfinavir

Interventions

Lamivudine/Zidovudine DRUG

Nelfinavir mesylate DRUG

Saquinavir DRUG

Delavirdine mesylate DRUG

Eligibility Criteria

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

This study has been terminated.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (17)

Willow Clinic

Menlo Park, California, 94025, United States

Location

Stanford Univ Med Ctr

Stanford, California, 943055107, United States

Location

Univ of Colorado Health Sciences Ctr

Denver, Colorado, 80262, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

Emory Univ

Atlanta, Georgia, 30308, United States

Location

Queens Med Ctr

Honolulu, Hawaii, 96816, United States

Location

Univ of Hawaii

Honolulu, Hawaii, 96816, United States

Location

Louis A Weiss Memorial Hosp

Chicago, Illinois, 60640, United States

Location

Tulane Univ School of Medicine

New Orleans, Louisiana, 70112, United States

Location

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, 14215, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Carolinas Med Ctr

Charlotte, North Carolina, 28203, United States

Location

Moses H Cone Memorial Hosp

Greensboro, North Carolina, 27401, United States

Location

Univ of Cincinnati

Cincinnati, Ohio, 452670405, United States

Location

Ohio State Univ Hosp Clinic

Columbus, Ohio, 432101228, United States

Location

Univ of Texas Galveston

Galveston, Texas, 775550435, United States

Location

Univ of Puerto Rico

San Juan, 009365067, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections

Interventions

lamivudine, zidovudine drug combination; Nelfinavir; Saquinavir; Delavirdine

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

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinolines; Piperazines; Heterocyclic Compounds, 1-Ring; Indoles

Study Officials

• Fischl M

  STUDY CHAIR

• Bartlett J

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

US (16); PR (1)