A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Suspended

CT.gov ID

NCT00002424

Collaborator

(none)

186

Enrollment

Locations

11.6

Patients Per Site

Study Details

Study Description

Brief Summary

This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and effective as taking 2 smaller doses twice a day.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: L-756423 Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine	Phase 2

Detailed Description

Patients are randomized to 1 of 4 treatment arms. In Group 1, patients receive a dose of L-756423/IDV once daily plus IDV placebo. In Group 3, patients receive a lower dose of L-756423/IDV twice daily (with the daily dosage equaling that of Group 1) plus IDV placebo. In Groups 2 and 4, patients receive equal dosages of IDV plus L-756423/IDV placebo. In all 4 groups L-756423 and IDV are blinded to the investigator and patient. All groups receive open-label d4T and 3TC. Patients routinely undergo a physical exam and have blood and urine tests to ensure the drugs' safety and tolerability, which will be evaluated by tabulation of adverse events and clinical assessment of laboratory data. In addition, CD4+ T cell and plasma viral RNA levels are measured to quantify the drugs' antiretroviral activity.

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Multicenter, Double-Blind, Randomized Pilot Study to Compare the Safety and Activity of L-756423/Indinavir, 1600/800 Mg Qd or 800/400 Mg Bid Versus Indinavir, 800 Mg q8h, All in Combination With Stavudine and Lamivudine

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

You may be eligible for this trial if you:

Have HIV infection.
Have levels of CD4 cells of 100 cells/mm3 or greater.
Have a viral load of 10,000 copies/ml or greater.
Are 18 years of age or older.

Exclusion Criteria

You may not be eligible for this trial if you:

Have ever taken anti-HIV drugs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA School of Medicine / Ctr for Research and Education	Los Angeles	California	United States	900951793
2	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	20007
3	ViRx / Dupont Circle Physicians Group	Washington	District of Columbia	United States	20009
4	Associates in Research	Fort Myers	Florida	United States	33901
5	Univ of Miami School of Medicine	Miami	Florida	United States	33136
6	Grady Mem Hosp	Atlanta	Georgia	United States	30308
7	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
8	The CORE Ctr	Chicago	Illinois	United States	60612
9	Univ of Kentucky Med Ctr	Lexington	Kentucky	United States	40536
10	Univ of Kentucky	Lexington	Kentucky	United States	40536
11	Beth Israel Deaconess Med Ctr	Boston	Massachusetts	United States	02215
12	Henry Ford Hosp	Detroit	Michigan	United States	48202
13	NYU Med Ctr / C & D Building	New York	New York	United States	10016
14	Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ	New York	New York	United States	10021
15	SUNY at Stony Brook / Div of Infectious Disease	Stony Brook	New York	United States	117948153
16	The Miriam Hosp	Providence	Rhode Island	United States	02906