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NCT00002406 Clinical Trial

A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients

HIV Infections Clinical Trial

Official title:
A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulphate, 800 Mg q 8h Versus 1,200 Mg q 12h in HIV-Infected Individuals Having Plasma Viral RNA Less Than 400 Copies/Ml, on Concomitant Therapy With 2 Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTI)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002406
Other study ID # 246P
Secondary ID MK-0639
Status Completed
Phase Phase 3
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date June 1999
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 determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).

Description:

In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms:

Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria

Patients must have:

- Documented HIV-1 seropositive status.

- CD4 count greater than 100 cells/mm3.

- Parental consent for patients under 18.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Indinavir sulfate

Locations
Country Name City State
United States Akron City Hospital Akron Ohio
United States Albany Med College / Div of HIV Medicine Albany New York
United States AIDS Research Consortium of Atlanta Atlanta Georgia
United States Ponce de Leon Ctr Atlanta Georgia
United States Natl Naval Med Ctr / Special Immunology Clinic Bethesda Maryland
United States 1917 Research Clinic Birmingham Alabama
United States Boston Med Ctr / Clinical Research Office Boston Massachusetts
United States Brigham and Women's Hosp Boston Massachusetts
United States SUNY / Health Science Ctr at Brooklyn Brooklyn New York
United States Education & Research Building Camden New Jersey
United States Northwestern Univ Med School Chicago Illinois
United States Rush Presbyterian St Lukes Med Ctr Chicago Illinois
United States Univ Health Ctr 7D Detroit Michigan
United States New York Hosp of Queens / AIDS Ctr Flushing New York
United States HIV Clinical Research Fort Lauderdale Florida
United States Houston Clinical Research Network / Southhampton Med Group Houston Texas
United States Kansas City Free Health Clinic Kansas City Missouri
United States Kaiser Permanente / Infectious Disease Los Angeles California
United States Tower ID Med Associates Los Angeles California
United States Univ of Miami School of Medicine Miami Florida
United States Anderson Clinical Research New York New York
United States CRIA New York New York
United States St Vincents Hosp and Med Ctr / Div of HIV Med New York New York
United States Thomas Jefferson Univ Philadelphia Pennsylvania
United States Anderson Clinical Research Pittsburgh Pennsylvania
United States Ctr for AIDS Research / Education and Service (CARES) Sacramento California
United States Univ of Utah School Of Medicine / Div of Infec Disease Salt Lake City Utah
United States San Francisco Gen Hosp / UCSF AIDS Program San Francisco California
United States Garden State Infectious Diseases / E I P Kennedy Health Sys Voorhees New Jersey

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

Country where clinical trial is conducted

United States, 

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