Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads

Completed · Phase 2

Conditions studied: HIV Infections

In brief

This study will look at people who have been taking anti-HIV drugs but still have detectable levels of HIV. The purpose of the study is to find out what happens in those people who change anti-HIV drugs when their viral load reaches 200 copies compared to those who change anti-HIV drugs when their viral load reaches 10,000 copies. This study will also look at drug resistance (how well HIV responds to drugs), viral fitness (how well drug-resistant HIV copies itself), and immunologic reconstitution (how well the immune system recognizes various infections, including HIV). Many patients experience virologic relapse (increase in viral load after sustained viral load suppression) within 1 to 2 years of taking anti-HIV drugs. The approach to treatment for patients who experience virologic relapse while on a highly active antiretroviral therapy (HAART) has not been defined. Current guidelines recommend switching to a new treatment regimen as soon as possible to prevent HIV from becoming even more resistant to anti-HIV drugs. However, there is evidence that patients can benefit from staying on the same HAART drugs, even after virologic relapse. This study wants to find what happens when drugs are changed immediately after virologic relapse (when the viral load is lower) compared to what happens if drugs are changed only after a delay (when the viral load is higher).

Key facts

Study ID

NCT00036465

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Expected to finish

2005-09-01

Last updated by the study team

2013-07-29

Who can join

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

You may qualify if…

• Patients may be eligible for this study if they:
• Are HIV-infected.
• Have a CD4 cell count of 200 cells/mm3 or more within 45 days prior to entry.
• Are currently receiving the same HAART regimen for at least 4 months.
• Had a documented viral load of less than 500 copies/ml at any time prior to screening on the current stable antiretroviral regimen.
• Have a detectable plasma viral load on current stable anti-HIV regimen, as defined in the protocol, within 52 weeks prior to screening.
• Are willing to remain on their current regimen until their scheduled switch.
• Have a negative pregnancy test within 48 hours prior to entry.
• Are at least 13 years old.
• Agree not to participate in the conception process (active attempts to become pregnant or to make someone pregnant) while on study and for 60 days after going off study.
• Agree to use 2 acceptable forms of contraception while on study and for 60 days after going off study.

You may not qualify if…

• Patients may not be eligible for this study if they:
• Do not adhere with current antiretroviral therapy.
• Have an infection or cancer that requires treatment within 45 days prior to entry.
• Are pregnant or breast-feeding.
• Have used any experimental agents, systemic corticosteroids, or drugs that interfere with the immune system within 45 days prior to entry.
• Have received any HIV vaccine within 90 days prior to entry.
• Use drugs or alcohol that, in the opinion of the investigator, would interfere with the study.

Where it is running

• Willow Clinic — Menlo Park, California, United States
• San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Harbor General/UCLA — Torrance, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Northwestern Univ — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• The CORE Ctr — Chicago, Illinois, United States
• Harvard (Masschusetts General Hosp) — Boston, Massachusetts, United States
• Brigham and Womens Hosp — Boston, Massachusetts, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Univ of North Carolina — Chapel Hill, North Carolina, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Univ of Cincinnati — Cincinnati, Ohio, United States
• Univ of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Brown Univ / Miriam Hosp — Providence, Rhode Island, United States
• Miriam Hosp / Brown Univ — Providence, Rhode Island, United States
• Comprehensive Care Clinic / Vanderbilt Univ Med Ctr — Nashville, Tennessee, United States
• Univ of Texas, Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Univ of Texas Galveston — Galveston, Texas, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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