Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00002241

Collaborator

(none)

Enrollment

Locations

4.4

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.

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

Detailed Description

Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Efficacy of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 100 Mg/d4T/3TC b.i.d. in HIV-Infected Individuals

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients may be eligible for this study if they:

Are HIV-positive.
Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more.
Are age 16 or older (consent of a parent or guardian required if under 18).
Agree to practice abstinence or use barrier methods of birth control (such as condoms).
Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.)

Exclusion Criteria

Patients will not be eligible for this study if they:

Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed).
Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV).
Have changed their medications in the last 2 weeks.
Are allergic to IDV, RTV, d4T, or 3TC.
Have used certain medications (see the technical summary for more detail).
Are pregnant or breast-feeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Apogee Med Group	San Diego	California	United States	92101
3	Univ of California at San Francisco Gen Hosp	San Francisco	California	United States	94110
4	HIV Institute / Davies Med Ctr	San Francisco	California	United States	94114
5	Kaiser Foundation Hospital	San Francisco	California	United States	94118
6	Univ of Miami School of Medicine	Miami	Florida	United States	33136
7	AIDS Research Alliance - Chicago	Chicago	Illinois	United States	60657
8	Tulane Univ School of Medicine	New Orleans	Louisiana	United States	70112
9	CRI New England	Brookline	Massachusetts	United States	02146
10	Bronx Lebanon Hosp Ctr	Bronx	New York	United States	10456
11	Montefiore Med Ctr	Bronx	New York	United States	10467
12	SUNY Health Sciences Ctr	Brooklyn	New York	United States	11203
13	Chelsea Village Med Ctr	New York	New York	United States	10014
14	Liberty Med Group	New York	New York	United States	10016
15	St Lukes / Roosevelt Hosp / HIV Center	New York	New York	United States	10019
16	Mount Sinai Med Ctr	New York	New York	United States	10029
17	Mark Watkins	Philadelphia	Pennsylvania	United States	19107
18	Univ of Texas / Thomas Street Clinic	Houston	Texas	United States	77030