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NCT00002236 Clinical Trial

A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients

HIV Infections Clinical Trial

Official title:
An Open-Label, Parallel Group, Pilot Study of Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of BID and TID Regimens of Delavirdine Mesylate, Zidovudine, and Indinavir Sulfate in HIV-1 Infected Individuals

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002236
Other study ID # 228G
Secondary ID M/3331/0072
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 whether it is better to take delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.

Description:

Patients are divided into 2 treatment groups; the groups are balanced with respect to viral load. Group A receives ZDV, DLV, and IDV 3 times daily. Group B receives ZDV, DLV, and IDV 2 times daily. Patients are evaluated for changes from baseline in viral load and CD4 cell count.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 14 Years and older
Eligibility Inclusion Criteria

You may be eligible for this study if you:

- Are HIV-positive.

- Have a viral load (level of HIV in the blood) of at least 20,000 copies/ml.

- Have a CD4 cell count of at least 50 cells/mm3.

- Are at least 14 years old (consent of parent or guardian is required if under 18).

Exclusion Criteria

You will not be eligible for this study if you:

- Have ever taken an anti-HIV drug other than ZDV.

- Have taken ZDV for more than 1 month.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Indinavir sulfate

• Delavirdine mesylate

• Zidovudine

Locations
Country Name City State
United States Infectious Disease Physicians Inc Annandale Virginia
United States AIDS Healthcare Foundation Los Angeles California
United States Univ of Tennessee / Div of Infect Dis / Dept of Med Memphis Tennessee
United States Saint Luke's - Roosevelt Hosp Ctr New York New York
United States Anderson Clinical Research Pittsburgh Pennsylvania
United States UCSF AIDS Research Institute San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Pharmacia and Upjohn

Country where clinical trial is conducted

United States, 

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