This study will determine which of four doses of GW873140 can safely be given to adults to
lower the amount of virus (HIV-1) in the body. GW873140 is a new type of anti-HIV drug called
a CCR5 receptor antagonist. CCR5 is a receptor on T cells (a type of white blood cell) where
HIV-1 enters and then infects the cell. GW873140 is intended to block the CCR5 receptor so
that HIV-1 cannot enter the cell.
HIV-1-infected patients 18 years of age and older may be eligible for this study. Candidates
are screened with a medical history and physical examination, electrocardiogram, and blood
and urine tests. Some of the blood drawn is used to test the patient's HIV-1 type to see if
the study drug might lower the amount of HIV-1 in the blood. Women who can become pregnant
have a pregnancy test.
Participants are hospitalized for 12 days. They are randomly assigned to take one of the
following four treatments for 10 days: 1) 200 mg of GW873140 once a day, or placebo (a
look-alike pill with no active ingredient); 2) 200 mg of GW873140 twice a day, or placebo; 3)
400 mg of GW873140 once a day, or placebo; or 600 mg of GW873140 twice a day, or placebo.
Participants record the meals they eat on a diary card. In addition, they undergo the
following tests and procedures:
During treatment
- Assessment of HIV classification (day 1)
- Review of meal diary cards (days 1,2,3,4,5,8, and 10)
- Review of any HIV-associated conditions, other medications taken besides the study drug,
and well-being (days 1,2,3,4,5,8,10, and 11)
- Check of vital signs, including blood pressure, pulse, and temperature (days
1,2,3,4,5,6,7,8,10, and 11)
- Weight assessment (days 1 and 10)
- Electrocardiogram to measure the electrical activity of the heart (days 1,2,3,8, and 10)
- Blood draws for routine laboratory tests, to measure T-cell counts, and to measure HIV
levels (days 1,2,5,10, and 11)
- Urine tests (days 1 and 10)
Post-treatment
- Blood tests to monitor the effect of GW873140 on lowering HIV counts (days 12, 15, 17,
and 19)
Follow-up visit (2 weeks after last drug dose--day 24)
- Review of medications taken and general well-being
- Check of vital signs
- Physical examination
- Blood and urine tests.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)