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Department of Medicine

Department of Medicine

   Division of Infectious Diseases

Research - Clinical Research


HIV Ongoing Clinical Trials


 Ongoing Clinical Trials


Title

ACTG A5315

Safety and Tolerability Study with a single dose of Romidepsin (RMD) for people taking antiretroviral drugs with an undetectable viral load

Description

This research study is designed to look at a one-time infusion of Romidepsin (RMD) to assess if it is safe and easy to tolerate, and to see if it can wake up the hidden or sleeping HIV virus. Each person will go into one of three groups (depending on when you enter this study) that will be assigned to one of three doses. Each group will enroll 15 subjects: 12 will receive RMD and 3 will receive a placebo (salt water solution) that does not contain RMD.  Participants will be followed for 4-8 weeks.

Contact Info

Telephone: 412-383-1748
Fax: 412-383-2900
Postal Address:
3520 Fifth Ave.                                                           
510 Keystone Bldg
Pittsburgh, PA 15213
Electronic mail (general info):
Renee Weinman

Title

ACTG A5332/A5333s

REPRIEVE -Randomized Trial to Prevent Vascular Events in HIV

Description

In this research study, people between the ages of 40 and 75 with HIV will be randomized to take a statin called pitavastatin OR a placebo by mouth to see if pitavastatin can help prevent heart disease and death in people who are taking HIV medication. Participants will be followed for up to 6 years.  The REPRIEVE trial will enroll 6500 participants from several countries, including up to 100 participants at the University of Pittsburgh. Participants in the REPRIEVE trial may also participant in a sub study that will obtain images of the coronary arteries by CT scan and evaluate immune activity biomarkers in the blood.

Contact Info

Telephone: 412-383-1748
Fax: 412-383-2900
Postal Address:
3520 Fifth Ave.                                                           
510 Keystone Bldg
Pittsburgh, PA 15213
Electronic mail (general info):
Renee Weinman

Title

ACTG A5346

Effect of Sitagliptin (Januvia) on Inflammation In Treated and Suppressed HIV Infection

Description

Since people started taking HIV medications, AIDS related illnesses have decreased but serious illnesses affecting other body organs have steadily increased. Heart disease, type 2 diabetes, cancer and other medical conditions are more common in people living with HIV than people who do not have HIV. HIV causes inflammation (irritation) inside the body. HIV medications reduce inflammation, but not completely.  Over time, this remaining inflammation can increase the risk for several diseases, including those mentioned above and others. Many HIV researchers are studying the harmful effects of this long-term inflammation and possible ways to reduce inflammation that may prevent these complications.
Sitagliptin (Januvia®) is an oral medication approved by the U.S Food and Drug Administration (FDA) to treat increased blood sugar levels in people with type 2 diabetes. Sitagliptin (Januvia®) is being investigated in this research study for its potential to reduce inflammation associated with HIV infection, a risk factor associated with non-AIDS complications.

Contact Info

Telephone: 412-383-1748
Fax: 412-383-2900
Postal Address:
3520 Fifth Ave.                                                          
510 Keystone Bldg
Pittsburgh, PA 15213
Electronic mail (general info):
Renee Weinman

Title

Dipyridamole for Immune Activation in HIV

Description

Since HIV-infected individuals started taking anti-HIV medications, illnesses from AIDS have decreased, but other serious diseases have increased. Researchers think this may be caused by an increase in activity of the immune system that fights infection, leading to inflammation.  Inflammation is a normal body reaction to any infection. However, if inflammation lasts a long time, like in HIV infection, it may lead to complications such as heart disease, cancer, liver disease, and problems with thinking. Many HIV researchers are studying the harmful effects of this prolonged immune system activity and inflammation and possible ways to prevent these complications.
The main purpose of this research study is to see how dipyridamole affects blood tests to measure immune system activity and inflammation and to look at the safety and tolerability of dipyridamole in people infected with HIV. This use of dipyridamole is investigational, or not approved by the FDA; however, the dose to be used in this study, 100mg four times a day, is the dose approved by the FDA for other conditions.

Contact Info

Telephone: 412-383-1748
Fax: 412-383-2900
Postal Address:
3520 Fifth Ave.                                                           
510 Keystone Bldg
Pittsburgh, PA 15213
Electronic mail (general info):
Renee Weinman

Title

Gilead Dose Escalation Study

Description

Antiretroviral medications can reduce HIV to very low levels in the blood and partially repair the immune system that helps your body fight infection. However, these medications do not eliminate the HIV infection, and a small amount of the virus continues to live in the body even when the viral load is very low, or below the limit of detection. This explains why the virus levels rebound or come back when these medications are stopped
This rebounding HIV is likely coming from cells that live for a long time after becoming infected with HIV. These cells are thought to carry the HIV in a hidden "sleeping" state. As long as the virus exists in this sleeping state, antiretroviral medications that block multiplying or "awake" virus cannot eliminate the HIV infection. The immune system does not seem to be able to eliminate these sleeping cells.
The purpose of this study is to evaluate an investigational medication, GS-9620, to determine if it is safe in HIV-infected persons and whether it can improve the immune response to HIV and temporarily increase the amount of virus produced by sleeping HIV-infected cells.

Contact Info

Telephone: 412-383-1748
Fax: 412-383-2900
Postal Address:
3520 Fifth Ave.                                                           
510 Keystone Bldg
Pittsburgh, PA 15213
Electronic mail (general info):
Renee Weinman

Title

HIV Assay- Optimization of Immunologic and Virologic Assays for HIV

Description

The Pitt Clinical Research Unit is a research clinic devoted to the study of experimental therapies and tests for HIV infection and its complications. The purpose of this study is to collect samples of blood from HIV negative and HIV-infected people to develop, improve, and check the accuracy of a variety of tests related to HIV research, such as tests to measure the body's reaction to HIV, to evaluate the body's response to HIV over time, and to measure the levels of HIV in the blood. These tests are called immunologic and virologic assays, and these assays may be useful in the future development of other therapies for HIV infection or an HIV vaccine.

Contact Info

Telephone: 412-383-1748
Fax: 412-383-2900
Postal Address:
3520 Fifth Ave.                                                          
510 Keystone Bldg
Pittsburgh, PA 15213
Electronic mail (general info):
Renee Weinman

Title

ACTG A5324

Description

A5324 is a research study for HIV-infected individuals with undetectable HIV viral load who have mild neurocognitive impairment. Subjects will be randomized to one of three study arms to add either placebo for maraviroc (MVC) and placebo for dolutegravir (DTG) (Arm A), DTG active drug and placebo for MVC (Arm B), or MVC and DTG active drugs (Arm C) to their existing antiretroviral therapy (ART).

Subjects will be assessed with neurocognitive tests and questionnaires about their daily functioning. There is an option to undergo lumbar punctures.

Contact Info

Telephone: 412-383-1748
Fax: 412-383-2900
Postal Address:
3520 Fifth Ave.                                                           
510 Keystone Bldg
Pittsburgh, PA 15213
Electronic mail (general info):
Renee Weinman

Title

EpiPrEP- Feasibility of Short-Term PrEP Uptake for MSM with Episodic High-Risk for HIV

Description

Truvada® has been approved by the Food and Drug Administration (FDA) for PrEP to reduce the risk of HIV infection. The purpose of the current study is to learn if PrEP taken daily for a 3 to 4 week period coinciding with a vacation is acceptable and tolerable for men who have sex with men. We are also interested in seeing how well participants are able to take PrEP as prescribed for that period.

Contact Info

Telephone: 412-383-1313
Fax: 412-383-2900
Postal Address:
3520 Fifth Ave.                                                           
510 Keystone Bldg
Pittsburgh, PA 15213
Electronic mail (general info):
Sherri Karas