About the GRACE Study

What Is GRACE?

GRACE is the largest HIV/AIDS study to date in North America of women who have received HIV treatment in the past. The GRACE Study looked at whether PREZISTA/Norvir® (ritonavir)* in combination with other antiretroviral (ARV) medications would have a different effect in women compared to men. All patients who participated in the study received PREZISTA at a dose of 600 mg twice a day plus Norvir® (ritonavir) at a dose of 100 mg twice a day in combination with other antiretroviral (ARV) medications chosen by the study physicians.

Women who have received HIV treatment in the past, particularly women of color, were the focus of the GRACE Study because of the disproportionate effect that HIV/AIDS has in this population throughout the country. Click on any of the links on the left to learn more.

The Vision of GRACE

Janssen Therapeutics, Division of Janssen Products, LP, the sponsor of the GRACE Study, partnered with practitioners who had experience and expertise treating women who received care in community healthcare settings and worked closely with communities nationwide to engage women in healthcare.

The researchers recognized that women with HIV/AIDS have distinctive needs with respect to participating in clinical trials and may require:

  • Transportation and child care
  • Counseling and/or emotional support from clinicians and other women living with HIV/AIDS
  • Information about benefits and risks of participation in clinical research
  • Additional assistance to stay involved

Support for Women With HIV/AIDS

A full support team for women with HIV/AIDS, particularly women of color, can help them connect to and stay in care for optimal treatment management.

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Janssen Therapeutics believed that this approach would encourage women to receive care, that they would be willing to stay in the clinical study, and that, beyond the study, this approach could help women with HIV/AIDS be successful in receiving care and staying in treatment.

*PREZISTA taken with Norvir® may be written as PREZISTA/Norvir® or PREZISTA/ritonavir or PREZISTA/r. This Web site uses PREZISTA/Norvir®.

ABOUT PREZISTA

PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.

PREZISTA is always taken with and at the same time as ritonavir (Norvir®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA should also be taken with food.

  • The use of other medicines active against HIV in combination with PREZISTA/ritonavir (Norvir®) may increase your ability to fight HIV. Your healthcare professional will work with you to find the right combination of HIV medicines
  • It is important that you remain under the care of your healthcare professional during treatment with PREZISTA

PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA is
right for you.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about PREZISTA?

  • PREZISTA, together with Norvir®, has been observed in a small number of patients to cause liver problems which may be life-threatening. Your healthcare professional should do blood tests prior to starting combination treatment including PREZISTA. If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems

    Talk to your healthcare professional about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea-colored) urine, pale-colored stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs
  • In a small number of patients, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare professional immediately if you develop a rash

Can PREZISTA be taken with other medications?

  • Taking PREZISTA with certain medicines could cause serious and/or life-threatening side effects or may result in loss of its effectiveness. Do not take PREZISTA if you are taking the following medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45® , Migranal®), ergonovine, ergotamine (Wigraine® , Ergostat® , Cafergot® , Ergomar®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral midazolam, triazolam (Halcion®), rifampin (Rifadin®,
    Rifater® , Rifamate®), sildenafil (Revatio®) when used to treat pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/ritonavir (Kaletra®), saquinavir (Invirase®), lovastatin (Mevacor® , Altoprev® , Advicor®), pravastatin(Pravachol®), simvastatin (Zocor® , Simcor® , Vytorin®), salmeterol (Serevent®), or products containing St. John's wort
  • Before taking PREZISTA, tell your health care professional if you are taking sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®, Adcirca®), atorvastatin (Lipitor®), atorvastatin/amlodipine (Caduet®), rosuvastatin (Crestor®), or colchicine (Colcrys®). This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements
  • Tell your healthcare professional if you are taking estrogen-based contraceptives (birth control). PREZISTA might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control, such as condoms

What should I tell my doctor before I take PREZISTA?

  • Before taking PREZISTA, tell your healthcare professional if you have any medical conditions, including allergy to sulfa medicines, diabetes, liver problems (including hepatitis B or C), or hemophilia
  • Tell your healthcare professional if you are pregnant or planning to become pregnant, or are breastfeeding
    • The effects of PREZISTA on pregnant women or their unborn babies are not known. You and your healthcare professional will need to decide if taking PREZISTA is right for you
    • Do not breastfeed if you are taking PREZISTA. You should not breastfeed if you have HIV because of the chance of passing HIV to your baby

What are the possible side effects of PREZISTA?

  • High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA
  • Changes in body fat have been seen in some patients taking HIV medicines, including PREZISTA. The cause and long-term health effects of these conditions are not known at this time
  • As with other protease inhibitors, taking PREZISTA may strengthen the body's immune response, enabling it to begin to fight infections that have been hidden. Patients may experience signs and symptoms of inflammation that can include swelling, tenderness, or redness
  • The most common side effects related to taking PREZISTA include diarrhea, nausea, rash, headache, stomach pain, and vomiting. Other important severe side effects include inflammation of the liver or pancreas and increased blood fat levels

This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA or any other medicines without first talking to your healthcare professional.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088

Please refer to the ritonavir (Norvir®) Product Information (Prescribing Information and Patient Information) for additional information on precautionary measures

Please see the full Product Information in PDF format for more details.