A Comparison of Two Anti-HIV Treatment Plans

Completed

Conditions studied: HIV Infections

In brief

The purpose of this study is to compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients who are resistant to the drug effects. Sometimes the increase in a patient's viral load (the level of HIV in the blood) can be slowed or stopped by taking anti-HIV drugs. This does not always happen. Sometimes anti-HIV drugs work at first but then stop working. When most of the usual anti-HIV drugs no longer seem to work, the virus is called multidrug-resistant (MDR). This study will compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients with MDR virus.

Key facts

Study ID

NCT00005915

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

480

Expected to finish

2004-06-01

Last updated by the study team

2013-10-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible if they:
• Have proof of MDR virus from a blood test.
• Have a viral load above 5,000 copies/ml from the same blood sample showing MDR virus.
• Intend to start a new anti-HIV treatment around the time of the study.
• Have been on a stable anti-HIV treatment between 14 days prior to the blood test mentioned above and when they are randomly assigned to a treatment.
• Are at least 13 years old (consent of parent or guardian required if under 18).
• (This protocol has been changed to reflect new criteria.)

You may not qualify if…

• Patients will not be eligible if they:
• Have received a vaccine or had an illness that might affect viral load within 14 days before the blood test showing MDR virus.
• Have received IL-2 within 4 months of the above-mentioned blood test or plan to take IL-2 during the study.
• Have an opportunistic (AIDS-related) infection requiring treatment.
• Are pregnant or breast-feeding.
• Are currently participating in CPCRA 057 (PIP study).

Where it is running

• Community Consortium / UCSF — San Francisco, California, United States
• Lawrence Goldyn, MD — San Francisco, California, United States
• Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
• Univ Hosp Infectious Disease — Denver, Colorado, United States
• Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit — New Haven, Connecticut, United States
• Washington Reg AIDS Prog / Dept of Infect Dis — Washington D.C., District of Columbia, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
• Our Lady of the Lake Regional Med Ctr — New Orleans, Louisiana, United States
• Wayne State Univ - WSU/DMC / Univ Hlth Ctr — Detroit, Michigan, United States
• Henry Ford Hosp — Detroit, Michigan, United States
• Southern New Jersey AIDS Clinical Trials — Camden, New Jersey, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Harlem AIDS Treatment Grp / Harlem Hosp Ctr — New York, New York, United States
• Bronx-Lebanon Hosp Ctr — The Bronx, New York, United States
• The Research and Education Group — Portland, Oregon, United States
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States
• Montrose Clinic — Houston, Texas, United States
• Houston Veterans Administration Med Ctr — Houston, Texas, United States
• Univ TX Health Science Ctr — Houston, Texas, United States
• Richmond AIDS Consortium / Div of Infect Diseases — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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