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

Sponsor

Pharmacia and Upjohn (Industry)

Overall Status

Completed

CT.gov ID

NCT00002236

Collaborator

(none)

Enrollment

Locations

5.3

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Indinavir sulfate Drug: Delavirdine mesylate Drug: Zidovudine	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AIDS Healthcare Foundation	Los Angeles	California	United States	90027
2	UCSF AIDS Research Institute	San Francisco	California	United States	94105
3	Saint Luke's - Roosevelt Hosp Ctr	New York	New York	United States	10019
4	Anderson Clinical Research	Pittsburgh	Pennsylvania	United States	15213
5	Univ of Tennessee / Div of Infect Dis / Dept of Med	Memphis	Tennessee	United States	38165
6	Infectious Disease Physicians Inc	Annandale	Virginia	United States	22203