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

Status unconfirmed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002241

Run by

Merck Sharp & Dohme LLC

People needed

80

Last updated by the study team

2005-06-24

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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