Comparing the Safety and Efficacy of Topical Gentian Violet Versus Nystatin Oral Suspension for the Treatment of Oropharyngeal Candidiasis in HIV-Infected People in Countries Outside of the United States
Oropharyngeal candidiasis (OC) is a common health issue for HIV-infected people. This study will compare the safety and effectiveness of nystatin oral suspension versus gentian violet (GV) for the treatment of OC.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III, Open-Label, Randomized, Assessment-Blinded Clinical Trial to Compare the Safety and Efficacy of Topical Gentian Violet to That of Nystatin Oral Suspension for the Treatment of Oropharyngeal Candidiasis in HIV-1 Infected Participants in Non-U.S. Settings|
- Lesion severity and extent (clinical efficacy) [ Time Frame: Measured at Day 14 ] [ Designated as safety issue: No ]Clinical efficacy is defined as cure (absence of lesions) or improvement (a decrease in severity and extent of lesions) after 14 days of treatment. Severity is scored using a scoring system from 0 to 3 (0 corresponds to absence of lesions, and 3 corresponds to presence of extensive confluent lesions).
- Level of discomfort and pain (symptoms) [ Time Frame: Measured at Week 13 ] [ Designated as safety issue: No ]Symptoms will be assessed using a visual analog scale where the level of discomfort and pain will be recorded and quantified using a scoring system from 0 to 3.
- Quantitative yeast colony counts [ Time Frame: Measured at Week 13 ] [ Designated as safety issue: Yes ]
- Emergence of fungal resistance [ Time Frame: Measured at Week 13 ] [ Designated as safety issue: Yes ]
- Emergence of adverse events [ Time Frame: Measured at Week 13 ] [ Designated as safety issue: Yes ]
- Participants' self-reported tolerance to assigned study medication (GV or nystatin) [ Time Frame: Measured at Week 13 ] [ Designated as safety issue: No ]
- Cost of treatment [ Time Frame: Measured at Week 13 ] [ Designated as safety issue: No ]
- Adherence to assigned study medication (GV or nystatin) [ Time Frame: Measured at Day 14 ] [ Designated as safety issue: No ]
- Participants' self-reported quality of life [ Time Frame: Measured at Week 13 ] [ Designated as safety issue: No ]
- Participants' self-reported acceptability of assigned study medication (GV or nystatin) [ Time Frame: Measured at Week 13 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
Experimental: Topical GV
Participants will receive topical GV solution for 14 days.
Drug: Topical GV
Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and spit twice a day) for 14 days
Active Comparator: Nystatin Oral Suspension
Participants will receive nystatin oral suspension for 14 days.
Drug: Nystatin Oral Suspension
Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow four times a day) for 14 days
OC is one of the most common opportunistic infections observed in HIV-infected people. OC occurs in approximately 60% of people with a CD4+ T-cell count of less than 100-200 cells/mm3. The incidence of OC has declined in industrialized countries following the introduction of highly active antiretroviral therapy (HAART). However, OC is still a problem for some people, even with the advent of HAART. Additionally, OC is the most common oral complication in HIV-infected people in resource-limited settings, with a reported prevalence rate ranging between 38-54% in Sub-Saharan Africa. Nystatin oral suspension is a common treatment for OC, especially in resource-limited settings outside of the United States. Preliminary research has shown that topical GV may also be effective at treating OC. GV is less expensive than nystatin, which is beneficial for people in countries with limited financial resources. The purpose of this study is to compare the safety and effectiveness of GV versus nystatin oral suspension at treating OC in HIV-infected people. The cost effectiveness of GV will also be analyzed.
This study will enroll HIV-infected people with OC. At a baseline study visit, participants will undergo a physical examination, medical history review, questionnaires, and a blood collection. They will also have an oral examination, mouth and throat swabbing, and an oral rinse procedure. Study researchers will take photographs of participants' mouths. Participants will then be randomly assigned to receive either GV or oral nystatin suspension for 14 days. Participants receiving GV will swish and spit out the solution twice a day, and participants receiving the nystatin suspension will swish and swallow the solution four times a day. Participants will record medication adherence in a diary. Study researchers will call participants 1 week after study entry to assess their health status. Additional study visits will occur at Weeks 2, 6, and 13 for repeat baseline testing.
|Gaborone Prevention/Treatment Trials CRS||Recruiting|
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|Molepolole Prevention/Treatment Trials CRS (Molepolole PTT CRS)||Recruiting|
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|NARI Pune CRS||Not yet recruiting|
|Pune, Maharashtra, India, 411026|
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|YRG CARE Medical Ctr., VHS Chennai CRS||Recruiting|
|Taramani, India, 600013|
|Contact: Jabin Sharma 91-44-39106709 firstname.lastname@example.org|
|MOI University Clinical Research Centre||Recruiting|
|Eldoret, Kenya, 30100|
|Contact: Priscilla C. Cheruiyot 254-532060850 email@example.com|
|Kenya Medical Research Institute/Walter Reed Project Clinical Research Centre (KEMRI/WRP CRC||Recruiting|
|Kericho, Kenya, 20200|
|Contact: Hellen Ngeno 254-5230388 firstname.lastname@example.org|
|College of Med. JHU CRS||Recruiting|
|Contact: Leslie Degnan 265-888-208609 email@example.com|
|Durban Adult HIV CRS||Recruiting|
|Durban, KwaZulu-Natal, South Africa, 4001|
|Contact: Rosie Mngqibisa, MB, BS 27-31-2604669 firstname.lastname@example.org|
|Kampala, Uganda, 10005|
|Contact: Sandra Rwambuya, MPH 256-41-4273515 email@example.com|
|Contact: Jimijika Batani 263-912272818 firstname.lastname@example.org|
|Study Chair:||Robert A. Salata, MD||Case Western Reserve University|