The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment

Status unconfirmed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to see if it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.

Key facts

Study ID

NCT00005118

Run by

Merck Sharp & Dohme LLC

People needed

100

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are HIV-positive.
• Are 18 years of age or older.
• Have a CD4 cell count of at least 50 cells/mm3.
• Have a viral load (level of HIV in the blood) of at least 400 copies/ml but no more than 20,000 copies/ml.
• Have had an initial response to protease inhibitor therapy with a viral load of less than 400 copies/ml in two consecutive tests at least 1 week apart.
• Have been on anti-HIV (antiretroviral) treatment including indinavir or nelfinavir for at least 16 weeks.
• Have had virologic failure (two consecutive viral loads that were greater than or equal to 400 copies/ml and less than or equal to 20,000 copies/ml at least 1 week apart) that is not due to another infection, vaccination, or a temporary stop in treatment.
• Are naive to at least one of the selected NRTIs.

Where it is running

• Pacific Oaks Research — Beverly Hills, California, United States
• Ocean View Internal Medicine — Long Beach, California, United States
• Bisher Akil — Los Angeles, California, United States
• Tower Infectious Diseases / Med Associates Inc — Los Angeles, California, United States
• UCSD Med Ctr - Owen Clinic — San Diego, California, United States
• HIV Institute / Davies Med Ctr — San Francisco, California, United States
• San Francisco Veterans Adm Med Cntr — San Francisco, California, United States
• Avalar Medical Group — Tarzana, California, United States
• Harbor - UCLA Med Ctr — Torrance, California, United States
• Benjamin Young — Denver, Colorado, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• Hillsborough County Health Dept — Tampa, Florida, United States
• Mercer University School of Medicine — Macon, Georgia, United States
• Thomas Coffman MD — Boise, Idaho, United States
• Chicago Ctr for Clinical Research — Chicago, Illinois, United States
• Northwestern Univ / Infect Dis Div / Pasavant Pav 828 — Chicago, Illinois, United States
• The CORE Ctr — Chicago, Illinois, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• University of Louisville / ID Division — Louisville, Kentucky, United States
• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• Institute of Human Virology — Baltimore, Maryland, United States
• New England Med Ctr — Boston, Massachusetts, United States
• Cooper Hospital Early Intervention Program — Camden, New Jersey, United States
• Dr Ronald Nahass — Somerville, New Jersey, United States

Full record on ClinicalTrials.gov

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