CLINICAL TRIALS PROFILE FOR COL-PROBENECID

All Clinical Trials for Col-probenecid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000670 ↗	Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate the interaction of probenecid with zidovudine (AZT). Because AZT is eliminated quickly from the body, it must be taken frequently. A previous study showed that probenecid slowed the elimination of AZT without side effects, but that study lasted only 5 days. This study is to see whether this effect continues for 1 month and whether the continuation of probenecid and AZT is free of side effects over 1 month.
NCT00000706 ↗	Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	Part I studies the effect of quinine on how zidovudine (AZT) is used by the body and eliminated through the kidneys in HIV infected patients. Part II studies the effect of probenecid and quinine on the same aspects. Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment.
NCT00000799 ↗	HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol	Completed	Gilead Sciences	N/A	1969-12-31	To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.
NCT00000799 ↗	HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.
NCT00000881 ↗	A Study of Cidofovir in HIV-Infected Children With Cytomegalovirus (CMV) Disease	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	Part A: To determine the safety and pharmacokinetics of sequential single doses of cidofovir in HIV-infected children with end-organ cytomegalovirus (CMV) disease. Part B: To determine the safety (including time to progression of CMV retinitis by retinal exam), pharmacokinetics, and long-term (6 months) tolerance of multiple-dose cidofovir in HIV-infected children with CMV retinitis. Part B: To determine the effect of multiple-dose cidofovir on the virologic parameters of CMV retinitis (viral load, shedding, and resistance to antiviral agents). [AS PER AMENDMENT 1/7/98: To determine the safety, tolerance and pharmacokinetics of sequential single doses of cidofovir in HIV-infected children with CMV retinitis. To determine the safety (including time to progression of CMV retinitis by retinal exam), pharmacokinetics, and long-term (6-month) tolerance of multiple doses of cidofovir in HIV-infected children with CMV retinitis.] While the intravenous formulation of cidofovir has been approved for the treatment of CMV retinitis in HIV-infected individuals, information is limited regarding its safety and tolerance in HIV-infected children. Intravenous cidofovir requires less frequent administration for both induction and maintenance therapy of CMV retinitis than other currently available therapies. If found to be safe and well tolerated in HIV-infected children with CMV retinitis, intravenous cidofovir would add significantly to agents available to treat this debilitating opportunistic infection.

Clinical Trial Conditions for Col-probenecid

Condition Name

Condition Name for Col-probenecid
Intervention	Trials
HIV Infections	10
Cytomegalovirus Retinitis	7
Healthy	6
Urinary Tract Infections	4

Condition MeSH

Condition MeSH for Col-probenecid
Intervention	Trials
HIV Infections	11
Communicable Diseases	8
Infections	7
Retinitis	7

Clinical Trial Locations for Col-probenecid

Trials by Country

Trials by Country for Col-probenecid
Location	Trials
United States	194
Canada	10
Germany	6
South Africa	6
Poland	5

Trials by US State

Trials by US State for Col-probenecid
Location	Trials
California	16
Texas	13
Ohio	10
New York	10
Maryland	8

Clinical Trial Progress for Col-probenecid

Clinical Trial Phase

Clinical Trial Phase for Col-probenecid
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	9
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Col-probenecid
Clinical Trial Phase	Trials
Completed	44
Not yet recruiting	8
Recruiting	5

Clinical Trial Sponsors for Col-probenecid

Sponsor Name

Sponsor Name for Col-probenecid
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	8
National Institutes of Health (NIH)	5
Iterum Therapeutics, International Limited	5

Sponsor Type

Sponsor Type for Col-probenecid
Sponsor	Trials
Industry	37
Other	33
NIH	21