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(MMA-0732) Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-7340 Monotherapy in Subjects with HIV-1 (GS-US-120-0104)

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A Phase I Randomized, Partially-Blinded, Active and Placebo- Controlled Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-7340 Monotherapy in Subjects with HIV-1 (GS-US-120-0104)

Principal Investigator:
Martin H. Markowitz M.D.

Saurabh Mehandru M.D.
Teresa Evering M.D.
Marina Caskey M.D.

Contact Information:
Melissa La Mar
Aaron Diamond AIDS Research Center
The Rockefeller University
1230 York Avenue
New York, NY 10065
Telephone: 212-327-7280
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
With an estimated 33.2 million people in the world infected with the virus, HIV is a major medical problem. The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of GS-7340 and to determine whether GS-7340 is effective against HIV-1 in subjects not currently receiving treatment for their chronic HIV-1 infection. The safety and tolerability of this drug will be determined on the basis of vital signs (i.e., pulse rate, breathing rate, body temperature, and blood pressure), physical exams, laboratory tests and questions about any problems you might experience during the study. The safety and effectiveness of GS-7340 will be compared with that of TDF.

Detailed Description of Protocol:
36 subjects will be recruited from about 8-10 study sites in the United States for this study. The screening period may last up to 42 days. Once you are confirmed to be eligible to participate in the study, and you state that you want to take part in the study, your participation in this study will last about 22 days, not including the screening visit. You will be required to visit the study center approximately 10 times. You will receive the study drug (GS-7340) TDF or placebo for 10 days.

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

- HIV +
- Have not received HIV medication in the past 3 months
- Do not have Hepatitis B or C



Children permitted to participate:

Potential Benefits.....
There is no guarantee that you will receive personal benefit from participating in this study. The study drugs are not expected to cure you of HIV. However, clinical research studies such as this are a way for doctors to determine if a drug is useful in fighting a disease. By participating in this study, you and the Sponsor, Gilead Sciences, Inc., may benefit if GS-7340 is effective in treating HIV-1 infection. Your participation in this study may benefit the community, scientists and doctors who work with HIV by providing increased knowledge and information about the treatment of your disease. In addition, during your participation you will have close medical monitoring of your health condition by blood tests and other evaluations during study center visits.

Volunteers will receive up to $950 for study completion.