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NCT00002211 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002211
Other study ID # 228E
Secondary ID 0073
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date April 2000
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nelfinavir mesylate

• Delavirdine mesylate

• Stavudine

• Didanosine

Locations
Country Name City State
United States Pharmacia & Upjohn Peapack New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Pharmacia and Upjohn

Country where clinical trial is conducted

United States, 

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