HIV in Specific Parts of the Body of Patients Who Are Changing or Starting Potent Anti-HIV Drugs

Completed

Conditions studied: HIV Infections

In brief

The purpose of this study is to gain information on how the type and amount of HIV present in certain places in the body and in the blood are affected when potent (powerful) anti-HIV drugs are given. Researchers know that the type and amount of HIV may differ in certain places in the body (called compartments) but are not sure how anti-HIV treatment affects these differences. This study gathers information to help understand how the virus grows and changes between blood and nonblood compartments in patients receiving anti-HIV treatment.

Key facts

Study ID

NCT00007488

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

164

Starts

2000-11-01

Expected to finish

2004-08-01

Last updated by the study team

2013-11-20

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 at least 13 years old.
• Are HIV-positive.
• Are changing or beginning anti-HIV therapy (not provided by the study). Anti-HIV therapy should be an approved 3-drug combination.
• Have a viral load of at least 2,000 copies/ml within 60 days of study entry.
• Have signed consent of parent or guardian if under 18 years of age.
• Are willing to contribute samples of blood, saliva, and either genital fluids or lymph tissue, or both, at study visits.
• Are willing to give permission to allow records from any coenrolled studies to be used while participating in this study.
• Have a negative pregnancy test within 14 days of study entry, if women able to have children. Women who become pregnant while on the study are allowed only to contribute blood and saliva samples until the pregnancy ends. After the pregnancy has ended, collection of genital fluids and/or lymphoid tissue will continue.
• Agree to receive HIV-related care at an AACTG site, if not enrolled in another AACTG trial.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have had any active opportunistic (AIDS-related) infection or disease, or have another illness occurring at the same time, or other infections, including an active lower genital tract infection that requires a new drug or change in drug in 14 days or less before study entry. There may be an exception for some conditions.
• Have used immunomodulatory agents in 14 days or less before study entry.
• Have had an immunization in 14 days or less before study entry.

Where it is running

• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• Willow Clinic — Menlo Park, California, United States
• Univ of California, San Diego — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• Univ of California San Francisco — San Francisco, California, United States
• San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Emory Univ — Atlanta, Georgia, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• The CORE Ctr — Chicago, Illinois, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Univ of Minnesota — Minneapolis, Minnesota, United States
• Washington Univ / St Louis Connect Care — St Louis, Missouri, United States
• Washington Univ School of Medicine — St Louis, Missouri, United States
• Community Health Network Inc — Rochester, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• Univ of North Carolina — Chapel Hill, North Carolina, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
• Brown Univ / Miriam Hosp — Providence, Rhode Island, United States
• Miriam Hosp / Brown Univ — Providence, Rhode Island, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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