Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00002451

Collaborator

(none)

Enrollment

Locations

2.7

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to see if it is safe to give indinavir (IDV) and ritonavir (RTV) in combination with stavudine (d4T) and lamivudine (3TC) to HIV-positive patients who have never received anti-HIV therapy. This study will look at the effectiveness of this drug combination and side effects.

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

Detailed Description

Patients entering this study initiate antiretroviral therapy. For 24 weeks patients receive daily dosages of IDV, RTV, 3TC, and d4T. Patients are seen at Day 1 and at Weeks 2, 4, 8, 12, 16, 20, and 24 for physical examinations, pregnancy testing, and blood sampling to monitor CD4 count and viral load. On Day 14, blood is drawn frequently for 24 hours for IDV and RTV pharmacokinetic sampling. The incidence of serious and drug-related adverse events and of adverse events leading to study discontinuation is tabulated.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Activity of Indinavir Sulfate 1200 Mg q.d. and Ritonavir 200 Mg q.d. in Combination With Stavudine and Lamivudine in Treatment Naive HIV-1 Infected Patients

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

Patients may be eligible for this study if they:

Are HIV-positive.
Are at least 18 years old.
Have a viral load of 5,000 copies/ml or greater.
Have a CD4 count of at least 50 cells/mm3.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have taken any antiretroviral (anti-HIV) agent.
Are pregnant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Miami School of Medicine	Miami	Florida	United States	33136
2	Albany Med College	Albany	New York	United States	12208
3	SUNY at Stony Brook / Division of Infectious Diseases	Stony Brook	New York	United States	11794