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Group 1: Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.

Group 2: Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.

Modified schedule of 60 milligrams/milliliter for 3-hour period 3 times/day for at least 5 days by aerosolization via a SPAG-2 generator via a face mask.

One time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day).

Roy F. Chemaly, MD

The goal of this clinical research study is to learn if ribavirin can help to control RSV in patients with immune systems that have been weakened by a stem cell transplant. Researchers also want to compare the effectiveness of the drug when it is given by mouth to when it is inhaled. The safety of the drug in both methods of delivery will be studied.

Ribavirin is designed to prevent the RSV virus from making more copies of itself in the body.

Study Groups:

If you are found to be eligible to take part in this study and the study doctor thinks that the disease requires treatment at this time, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group:

* If you are in Group 1, you will receive the inhaled form of ribavirin. You will inhale ribavirin 3 times a day for 3 hours each time in a tent in a hospital room. You will receive the drug for up to 10 days.
* If you are in Group 2, you will take capsules of ribavirin 3 times a day for up to 10 days.

If the study doctor does not think that the disease requires treatment at this time, you will be assigned to Group 3. If you are in Group 3, you will not receive treatment with ribavirin, but you will have the same tests and procedures at the study visits described below.

Study Visits:

At all study visits, you will be asked about how you are feeling, about any side effects or symptoms you may be having, and about any other drugs you may be taking.

On Day 3 (+/- 1 day):

* You will have a physical exam, including measurement of your vital signs
* Your nasal passages will be checked for RSV.

On Days 7 and 14 (+/- 1 day):

* Blood (about 2 teaspoons) will be drawn for routine tests.
* You will have a physical exam, including measurement of your vital signs
* Your nasal passages will be checked for RSV.

Length of Study:

If you are in Groups 1 or 2, you will receive the study drug for up to 10 days. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. If your doctor thinks you need treatment longer than 10 days, you will receive that as part of your routine care. This may mean changing to receiving the drug in inhaled form if you began the study receiving it by mouth.

All participants will have end-of-study and follow-up visits, as described below.

End-of-Study Visit:

If you are in Groups 1 or 2, the end-of-study visit will be about 14 days after your last dose of the study drug. If you are in Group 3, the end-of-study visit will take place at about Day 21. The following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* Blood (about 4 teaspoons) will be drawn for routine tests and to check for RSV antibodies.
* Your nasal passages will be checked for RSV.
* You will be asked about how you are feeling, about any side effects or symptoms you may be having, and about any drugs you may be taking.

Follow-Up Visit:

About 6 to 10 weeks after your last dose of study drug, you will have a pulmonary function test to check your lung function.

This is an investigational study. Ribavirin is FDA approved and commercially available for the treatment of hepatitis C when given by mouth, and for severe RSV in children when inhaled. Giving the drug to adults with weak immune systems after a stem cell transplant is investigational.

Up to 96 patients will take part in this study. All will be enrolled at MD Anderson.

Respiratory Syncytial Virus - RSV Protocol

An Open Label Randomized Controlled Trial To Prevent the Progression of Respiratory Syncytial Virus Upper Respiratory Tract Infection to Lower Respiratory Tract Infection in Patients After Hematopoietic Stem Cell Transplant

Patient who developed signs of lower respiratory tract infection

M.D. Anderson Cancer Center

Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.

Oral Ribavirin

Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.

Inhaled Ribavirin

No Ribavirin

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

One patient from the Oral ribavarin group withdrew consent.

Roy F. Chemaly, MD,MPH- Professor, Infectious Diseases

Percentage of Participants With Progression to Lower Respiratory Tract Infection (LRI)

Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.

Ribavirin: One time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Respiratory Syncytial Virus - RSV Protocol	NCT01502072	Bone Marrow Tra... Infection in Ma... Respiratory Syn... Respiratory Syn... Cancer Acute Leukemia	Ribavirin Ribavirin	18 Years -	M.D. Anderson Cancer Center
Respiratory Syncytial Virus - RSV Protocol	NCT01502072	Bone Marrow Tra... Infection in Ma... Respiratory Syn... Respiratory Syn... Cancer Acute Leukemia	Ribavirin Ribavirin	18 Years -	M.D. Anderson Cancer Center
Respiratory Syncytial Virus - RSV Protocol	NCT01502072	Bone Marrow Tra... Infection in Ma... Respiratory Syn... Respiratory Syn... Cancer Acute Leukemia	Ribavirin Ribavirin	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for lower respiratory tract infection