Safety and Effectiveness of Giving Combinations of Three or Four Anti-HIV Drugs to HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002211
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 2000
  Purpose

The purpose of this study is to see if it is safe and effective to give combinations of three or four anti-HIV drugs to HIV-infected patients. The drugs used in this study are delavirdine (DLV), nelfinavir (NLF), didanosine (ddI), and stavudine (d4T).


Condition Intervention
HIV Infections
Drug: Nelfinavir mesylate
Drug: Delavirdine mesylate
Drug: Stavudine
Drug: Didanosine

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) Plus Nelfinavir (NFV), Didanosine (ddI), and Stavudine (d4T) in Triple and Quadruple Treatment Regimens in HIV-1 Infected Individuals

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 160
Detailed Description:

This is a multicenter, open-label study. Patients are stratified by HIV-1 RNA levels (20,000 to 200,000 copies/ml and greater than 200,000 copies/ml). Patients are equally randomized to one of four groups and receive antiretroviral therapy for 24 weeks. Group 1 receives delavirdine (DLV) plus nelfinavir (NFV) plus stavudine (d4T). Group 2 receives DLV plus NFV plus didanosine (ddI). Group 3 receives NFV plus d4T plus ddI. Group 4 receives DLV plus NFV plus d4T plus ddI. Patients are evaluated for drug safety and viral burden. Patients may opt to continue on the study for 24 additional weeks, at the discretion of the investigator.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

You may be eligible for this study if you:

  • Are at least 18 years old.
  • Are HIV-positive.
  • Have a CD4 count of at least 50 cells/mm3.
  • Have a viral load of at least 20,000 copies/ml.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have taken d4T.
  • Have taken protease inhibitors, including NFV.
  • Have taken nonnucleoside reverse transcriptase inhibitors.
  • Have taken ddI for 1 month or more.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002211

Locations
United States, New Jersey
Pharmacia & Upjohn
Peapack, New Jersey, United States, 07977
Sponsors and Collaborators
Pharmacia and Upjohn
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002211     History of Changes
Other Study ID Numbers: 228E, 0073
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Didanosine
Stavudine
HIV Protease Inhibitors
RNA, Viral
Delavirdine
Reverse Transcriptase Inhibitors
Viral Load
Nelfinavir

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Didanosine
Stavudine
Reverse Transcriptase Inhibitors
Delavirdine
Nelfinavir
HIV Protease Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014