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A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002401
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).

Condition or disease Intervention/treatment
HIV Infections Drug: Indinavir sulfate Drug: Delavirdine mesylate Drug: Lamivudine Drug: Zidovudine

Detailed Description:

In this open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks:

Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC.

  • Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Primary Purpose: Treatment
Official Title: An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in HIV-1 Infected Individuals

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Prior Medication:

Allowed:

Less than 1 month prior treatment with zidovudine.

Exclusion Criteria

Prior Medication:

Excluded:

  • Prior indinavir.
  • Prior lamivudine.
  • Prior protease inhibitors.
  • Prior non-nucleoside reverse transcriptase inhibitors.
  • 1 month or more prior zidovudine.

    1. HIV-1 positive.

  • CD4 coun tis above 50.
  • HIV-1 RNA levels greater than 20,000.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002401


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

ClinicalTrials.gov Identifier: NCT00002401     History of Changes
Other Study ID Numbers: 228F
0074
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 1999

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Zidovudine
HIV Protease Inhibitors
Lamivudine
Indinavir
RNA, Viral
Delavirdine
Reverse Transcriptase Inhibitors
Viral Load

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine
Zidovudine
Delavirdine
Indinavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Antimetabolites
HIV Protease Inhibitors
Protease Inhibitors