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| Principal Investigator: | Donna Mildvan, MD | |
| Time frame of study: | Ongoing | |
| Time frame of participation: | Up to 48 weeks | |
| Number of participants needed: | Open | |
| Location of Study: | Beth
Israel Medical Center |
|
| Contact Name, Number & Email: | (212)420-4519 or (800) 483-7339 |
Summary:
ACTG
A5216;A Randomized Phase II Study of the Safety, Immunologic and Virologic
Effects of Cyclosporine A in Conjunction with Trizivir and Kaletra versus
Trizivir and Kaletra Alone during Primary HIV-1 Infection
This study is being done to determine if taking cyclosporine A (an immunosuppressant used in organ and tissue transplantation) shortly after infection with HIV and at the time anti-HIV medications are begun will reduce the amount of HIV in the blood as well as increase the overall number of T-cells while decreasing the number of T cells that are infected with HIV.
Study Design:
Upon entry into the study,
participants will be randomized (like flipping a coin) to one
of two study groups:
Arm A
· Weeks 1-4: Kaletra (a protease inhibitor) PLUS Trizivir (combination
of AZT, 3TC, and Ziagen, all 3 are nucleoside reverse transcriptor inhibitors,
or NRTIs) PLUS cyclosporine A.
· Weeks 5-48: Kaletra
PLUS Trizivir
Arm B
· Weeks 1-48: Kaletra PLUS Trizivir
Criteria for
Participation:
Acute HIV-1 infection, defined as documentation of the following within
14 days prior to entry:
- HIV viral load greater than 500,000 AND
- Negative ELISA OR
- Negative Western Blot (with 3 bands or less)
- Negative for hepatitis B and hepatitis C
Compensation:
Transportation reimbursement provided.