HIV / AIDS

0104 Study — CLOSED to enrollment

A phase three, randomized, double-blind study to evaluate the safety and efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 positive, antiretroviral treatment-naïve adults.

0109 Study — CLOSED to enrollment

0111 Study — CLOSED to enrollment

0112 Study — CLOSED to enrollment

ADVICE — CLOSED to enrollment

ARIES Study — CLOSED to enrollment

The ARIES study is a randomized, open-label, multi-center study that aims to explore the safety and efficacy of an initial regimen that includes highly active antiretroviral therapies (HAART) and a protease inhibitor. Combination antiretroviral therapy regimens for the treatment of HIV infection have been shown to result in durable and substantial viral load reductions that can delay the progression of HIV and prolong survival. The primary objective of the ARIES study is to evaluate the efficacy, safety, tolerability and durability of the antiviral response between Atazanavir (ATV) + Ritonavir (RTV) and a fixed-dose of Abacavir sulfate for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV+RTV for an additional 48 weeks each in combination with the Abacavir sulfate. New drugs and clinical data necessitate ongoing evaluation of the best treatment choices since ART regimen selection remains a dynamic process.

ASSURE Study — CLOSED to enrollment

BEIJERINCK - CLOSED to enrollment

BEIJERINCK: (evolocumaB Effect on LDL-C lowerIng in subJEcts with human immunodeficiency viRus and INcreased Cardiovascular risK.) Conducted in collaboration with Amgen pharmaceuticals. The purpose of this trial is to test the cholesterol lowering effects of evolocumab when given to HIV+ patients who are unable to achieve recommended cholesterol levels using ‘statin’ medications. HIV patients are at increased risk for heart disease and lowering cholesterol is one of the most effective prevention strategies. Candidates for this study must have an undetectable viral load while taking antiretroviral treatment for HIV, have elevated LDL cholesterol levels and be either: a) on the maximum recommended dose of a ‘statin’ medication, or b) unable to tolerate a ‘statin’ medication.

ECSTATIN - CLOSED to enrollment

Conducted in collaboration with the National Institute of Allergy and Infectious Diseases (at the National Institutes of Health). The purpose of this trial is to test the potential anti-inflammatory benefits of aspirin and atorvastatin (a cholesterol medicine) among HIV positive patients who’s viral load is “undetectable” when not taking treatment (sometimes referred to as elite controllers). Participants will have to visit the National Institutes of Health (NIH), in Bethesda, Maryland, every three months (for 15 months) where they will have all study visit procedures performed. Visits in Maryland will last 1–2 days and the NIH will pay for all study related travel, logding and food for participants during the trip. Candidates for this study must be an elite controller, as defined by an “undetectable” viral load with no antiretroviral treatment. You must not have been on a statin or aspirin in the last six months. To find out more about this study or to determine eligibility, please contact Andrea Dolan at 612-873-7678.

ELITE Study — CLOSED to enrollment

After being infected with HIV, most persons experience progression of HIV. However, few (approximately 1% – 2% of persons infected with HIV) persons maintain HIV viral loads below the limits of detection without antiretroviral medications. The HIV Controller Consortium proposes to perform detailed genetic testing in the small subset of persons who maintain undetectable HIV viral loads without antiviral therapy. Through a nationwide collaborative effort with academic institutions and primary care physicians, a cohort of 180 persons that we call “HIV controllers” (persons who maintain undetectable HIV viral loads without ever receiving antiretroviral therapy) will be established. The primary goal of this study is to gain a better understanding of the spontaneous control of HIV replication using human genetic tests. The Elite Study will provide a unique opportunity to determine the extent to which persistent control of the HIV virus is possible. Understanding the reasons why some individuals are able to maintain such control is a critical issue, since the first generation of an AIDS vaccine would be considered a success if it were able to create such a state of control following an exposure to HIV.

Gilead Protocol 102 Study — CLOSED to enrollment

Gilead 103 Study (GS-US-236-0103) — CLOSED to enrollment

Gilead 103 a phase three, randomized, double-blind study designed to evaluate the safety and effectiveness of two antiretroviral regimen combinations; Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 and Ritonavir-boosted Atazanavir combined with Emtricitabine/Tenofovir Disoproxil Fumarate. A secondary goal is to determine the efficacy and tolerability of both treatment regimens based upon a 96 week period. Gilead 103 hopes to enroll approximately 700 participants that are HIV-1 positive and have never taken antiretroviral medication (with plasma HIV-1 RNA levels ≥ 5,000 copies/mL). After the designated timetable of 96 weeks is over, subjects will continue to take their designated drug and participate in visits every 12 weeks until their treatment is unblinded. After this point study subjects will have the option of participating in an another open-label rollover study to receive the EVG/FTC/TDF/GS-9350 fixed-dose combination tablet until it either becomes commercially available or Gilead Sciences decides to discontinue its development.

Gilead 106 Study — CLOSED to enrollment

A phase three randomized, open-label study to evaluate switching from regimens consisting of a Ritonavir-boosted protease inhibitor and two nucleoside reverse transcriptase inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) fixed-dose regimen in virologically-suppressed, HIV-1 infected patients.

Persons may be eligible for this study if they:

are on their first OR second line of HIV therapy and taking Ritonavir
have an undetectable viral load
are willing to be randomized to possibly switch to a one pill, once a day, option

Gilead 110 Study — CLOSED to enrollment

Gilead 114 Study (GS-US-216-0114) — CLOSED to enrollment

Gilead 114 is a phase three, randomized, double-blind study that is designed to evaluate the safety and effectiveness of GS-9350; which is an experimental drug which functions as a “booster” when taken with other classes of HIV drugs called protease and intergrase inhibitors. This study will explore the efficacy of GS-9350 when given in combination with Atazanavir and Truvada in reducing levels of HIV-1 in the blood of subjects who have never taken any antiretroviral medication.

The safety and effectiveness of GS-9350 will be compared with that of a similar “booster” drug called Ritonavir over a time period of 96 weeks. Gilead hopes to enroll approximately 700 participants in the 114 study with two groups of 350 subjects taking either GS-9350-boosted Atazanavir or Ritonavir-boosted Atazanavir (each administered with Emtricitabine/Tenofovir Disoproxil Fumarate). After the designated timetable of 96 weeks is over, subjects will continue to take their designated drug and participate in visits every 12 weeks until their treatment is unblinded. After this point study subjects will have the option of participating in an another open-label rollover study to receive GS-9350-boosted ATV+FTC/TDF until GS-9350 either becomes commercially available or Gilead Sciences decides to discontinue its development.

Gilead 115 Study — CLOSED to enrollment

Gilead 121 Study — CLOSED to enrollment

Gilead 130 Study — CLOSED to enrollment

Gilead 292 102 Study — CLOSED to enrollment

Gilead 299 102 Study — CLOSED to enrollment

GSK FLAMINGO Study — CLOSED to enrollment

GSK LATTE Study — CLOSED to enrollment

LIFE-HIV — CLOSED to enrollment

(Losartan to reduce Inflammation and Fibrosis Endpoints in HIV disease): The purpose of this study is to find out if an FDA approved medication (losartan) can reduce inflammation and improve immune recovery, by reducing damage within immune tissue (e.g. related to scar formation in lymph nodes) among individuals with HIV infection. Losartan is approved as a blood pressure lowering drug, but his has additional known properties that may reduce inflammation and reverse immune. The study lasts one year, and research visit procedures include blood draws and periodic lymph node biopsies (two times).

Pfizer MODERN Study — CLOSED to enrollment

Reasonable Approach to Examining Medication Taking Behavior in African American Women — CLOSED to enrollment

African American women living with HIV… taking medicine is hard. Lots of people miss doses. The goal of this study is learn more about the lives of African American women living with HIV to better understand how to help.

If you are an African American women living with HIV, taking at least one antiretroviral agent and between the ages of 18-60, you may be eligible to participate.

You will be asked to complete a memory test and answer some questions about HIV, taking medicine, spirituality, how you feel, and your relationships with other people. The study visit will take less than one hour. You will be given $20 after answering questions during the study visit.

SAILING Study — CLOSED to enrollment

SINGLE Study — CLOSED to enrollment

START Study — CLOSED to enrollment

Strategic Timing of AntiRetroviral Treatment (START) is a multi-site, international study that will be carried out in two phases; a pilot and definitive phase. The pilot phase aims to enroll 900 participants in the first year. The definitive phase aims to enroll up to 4,000 participants. START will examine the benefits of beginning antiretroviral treatment early against the risks of side effects and drug resistance. Participants will be randomized to one of two groups; 1) starting antiretroviral therapy (ART) when the CD4 cell count is greater than 500 mm3 OR 2) starting ART when the CD4 cell count is below 350 mm3. Currently, ART is clinically indicated when the CD4 cell count is lower than 350 mm3. Results from START will help inform future HIV treatment guidelines. Participants will receive ART at no cost.

SWIFT and GILEAD AE Studies — CLOSED to enrollment

Some HIV medications may influence risk for heart disease, but the effect may be quite different for different HIV medications. Several research studies have attempted to answer the question, “Is Abacavir use related to increased risk for heart disease?” Despite several studies examining the relationship between Abacavir and heart disease, the question is unanswered. The SWIFT and Gilead AE studies are looking at whether markers for heart disease change if persons taking Abacavir change to another, very similar, HIV medication. Patients that are currently taking Abacavir and Lamivudine (co-formulated as ‘Epzicom’) and have a ‘suppressed viral load’ may be eligible to participate in these studies. Participants will either continue to take ‘Epzicom’ or will switch to a medication called ‘Truvada’ (Tenofovir DF and Emtricitabine), and will complete five, approximately 60 minute, study visits over one year. Participants will be compensated in cash for their time and travel expenses.

TACTICAL — CLOSED to enrollment

(Targeted AntiCoagulation Therapy to reduce Cellular Activation during Longstanding HIV disease): The focus of this study is to reduce risk for heart disease and other complications of aging among HIV-positive persons. HIV infection increases inflammation and coagulation, or blood clotting, which contributes to diseases of the heart and other organs. The treatment is ‘edoxaban’, which is a blood thinner (or ‘anti-coagulant’) that may improve both inflammation and coagulation abnormalities.

The SUN Study — CLOSED to enrollment

Study to Understand the Natural History of HIV and AIDS. Primary objective of this study is to determine the occurrence and risk factors for non-AIDS defining conditions in HIV-infected patients who are receiving regular HIV and other medical care. The SUN Study will be evaluating HIV primary prevention through screening; treatment and counseling about STDs and HIV risk behaviors. At least 500 participants who are relatively early or mid-point in the course of their HIV infection and treatment will be monitored by various tests. Regular Dexa scanning for bone and fat problems, initial cardiovascular, renal, liver and other tests will be utilized in managing participants care.

Key Researcher