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NCT00002241 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00002241
Other study ID # 246T
Secondary ID 094-00CRX463
Status Active, not recruiting
Phase Phase 2
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date July 2001
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 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 80
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Indinavir sulfate

• Ritonavir

• Lamivudine

• Stavudine

Locations
Country Name City State
United States Univ of Alabama at Birmingham Birmingham Alabama
United States Bronx Lebanon Hosp Ctr Bronx New York
United States Montefiore Med Ctr Bronx New York
United States CRI New England Brookline Massachusetts
United States SUNY Health Sciences Ctr Brooklyn New York
United States AIDS Research Alliance - Chicago Chicago Illinois
United States Univ of Texas / Thomas Street Clinic Houston Texas
United States Univ of Miami School of Medicine Miami Florida
United States Tulane Univ School of Medicine New Orleans Louisiana
United States Chelsea Village Med Ctr New York New York
United States Liberty Med Group New York New York
United States Mount Sinai Med Ctr New York New York
United States St Lukes / Roosevelt Hosp / HIV Center New York New York
United States Mark Watkins Philadelphia Pennsylvania
United States Apogee Med Group San Diego California
United States HIV Institute / Davies Med Ctr San Francisco California
United States Kaiser Foundation Hospital San Francisco California
United States Univ of California at San Francisco Gen Hosp San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

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