- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00855062
Minocycline for HIV+ Cognitive Impairment in Uganda
Minocycline in the Treatment of HIV-Associated Cognitive Impairment in Uganda
Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline, an antibiotic, in the treatment of Human immunodeficiency virus (HIV)-associated cognitive impairment in Uganda.
Study Design: Treatment, 24-week Randomized, Placebo-Controlled, Double-Blind Phase with Optional 24-week Open Label Phase for Subjects with a cluster of differentiation 4 (CD4) Count in the 251-350 Range
- Arm 1: Minocycline 100 mg orally every 12 hours (50 subjects)
- Arm 2: Matching placebo orally every 12 hours (50 subjects)
Primary Objective:
· To examine whether minocycline treatment will improve cognitive performance after 24 weeks compared to baseline
Secondary Objectives:
- To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment
- To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment
- To examine whether minocycline treatment for 24 weeks improves functional impairment
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Kampala, Uganda
- Infecious Diseas Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HIV infection prior to study entry
- Naïve to any antiretroviral regimen and ineligible to receive antiretroviral therapy by cluster of differentiation 4 (CD4) criteria in Uganda
- Negative serum or urine pregnancy test for women of childbearing potential
- Willingness to use birth control
- Age 18-65 years
- AIDS Dementia Scale Stage 0.5 OR 1
- Impaired cognitive performance as evidenced by an International HIV Dementia Scale (HDS) as defined by the protocol
- Ability to sit or stand and swallow intact capsules with an 8-ounce glass of water
- Ability and willingness of subject or legal guardian/ representative to give written informed consent
- Resident within a 20km radius of Kampala city
Exclusion Criteria:
- Current cancers other than basal cell carcinoma, in situ carcinoma of the cervix, or Kaposi's sarcoma without evidence of visceral involvement or which does not require systemic chemotherapy
- Severe premorbid psychiatric illness, including schizophrenia and major depression which, in the in investigator's opinion, is likely to interfere with study compliance
- Active symptomatic AIDS-defining opportunistic infection within 45 days prior to study entry
- Confounding neurological disorders as defined in the protocol
- Central nervous system infections or cancers as defined in the protocol
- Systemic lupus
- Thyroid disease diagnosed within 24 weeks prior to entry
- Breastfeeding
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator
- History of allergy/sensitivity to minocycline or other tetracyclines and their formulations
- Any other clinically significant condition or laboratory abnormality that, in the opinion of the investigator, would interfere with the subject's ability to participate in the study. This includes an individual found to have an HIV dementia scale stage 3 or 4.
- Any esophageal or other condition that would interfere with the swallowing of the study medication
- Use of excluded drugs as defined by the protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Minocycline
Minocycline 100 mg orally every 12 hours
|
100 mg capsule every 12 hours by mouth
|
Placebo Comparator: Placebo
Placebo minocycline capsules every 12 hours
|
1 capsule every 12 hours by mouth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
24-week Change of Uganda Neuropsychological Test Battery Summary Measure (U NP Sum)
Time Frame: At baseline and week 24
|
The U NP Sum is defined as the average of z scores for 9 neuropsychological test subcomponents in the neuropsychological test battery (i.e. the average of norm-adjusted ("z") scores for Grooved Pegboard Dominant Hand, Grooved Pegboard Non-dominant Hand, Color Trails 1, Color Trails 2, Symbol Digit, WHO-UCLA Verbal Learning test Trial 5, WHO-UCLA Verbal Learning test delayed recall, Digit Span forward and Digit Span backward).
The outcome is defined as U NP Sum at week 24 - U NP Sum at baseline.
|
At baseline and week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
24-week Change of Memorial Sloan Kettering (MSK) HIV Dementia Stage
Time Frame: At baseline and week 24
|
The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.
|
At baseline and week 24
|
24-week Change of Karnofsky Performance Score
Time Frame: At baseline and week 24
|
The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.
|
At baseline and week 24
|
Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms.
Time Frame: Time of initial Grade ≥ 2 toxicity and/or sign and symptom event up to week 24
|
The outcome is the time to first Grade ≥ 2 toxicity and/or sign and symptoms from study treatment initiation up to week 24.
The grade was determined by clinicians and an Grade ≥ 2 event means moderate, severe, life-threatening, or death event.
|
Time of initial Grade ≥ 2 toxicity and/or sign and symptom event up to week 24
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Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms
Time Frame: Time of first Grade ≥ 2 toxicity and/or sign and symptom event up to 48 weeks
|
The outcome is the time of first Grade ≥ 2 toxicity and/or sign and symptoms from treatment initiation up to 48 weeks.
The grade was determined by clinicians and an Grade ≥ 2 event means moderate, severe, life-threatening, or death event.
|
Time of first Grade ≥ 2 toxicity and/or sign and symptom event up to 48 weeks
|
24-week Change of CD4 Cell Counts
Time Frame: At baseline and week 24
|
The outcome is defined as CD4 cell count at week 24 - CD4 cell count at baseline.
The unit is cells/mm^3.
|
At baseline and week 24
|
48-week Change of CD4 Cell Counts
Time Frame: At baseline and week 48
|
The outcome is defined as CD4 cell count at week 48 - CD4 cell count at baseline.
The unit is cells/mm^3.
|
At baseline and week 48
|
24-week Change of Instrumental Activities of Daily Living
Time Frame: At baseline and week 24
|
The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.
|
At baseline and week 24
|
24-week Change of HIV RNA Plasma Viral Loads (Log10 Transformed)
Time Frame: At baseline and week 24
|
The outcome is the HIV RNA plasma viral loads (Log10 transformed) at week 24 - the viral loads (Log10 transformed) at baseline.
|
At baseline and week 24
|
24-week Change of Center for Epidemiologic Studies Depression (CES-D) Score
Time Frame: At baseline and week 24
|
The outcome is the total CES-D score at week 24 - the total CES-D score at baseline. The total CES-D score is based on 20 CES-D items, such as "I was bothered by things that usually don't bother me" and "I did not feel like eating, my appetite was poor". Patients were asked to answer each item by 4 scales: (1) Rarely, (2) Sometimes, (3) Occasionally, and (4) Most of the time. After 4 negative items were multiplied by -1, the total CES-D score is a simple sum of all items. The min and Max are 0 and 60, respectively. Higher scores indicate more severe depressive symptoms. |
At baseline and week 24
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ned Sacktor, MD, Johns Hopkins School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uganda minocycline study
- Grant Number: 5 UO1 NS32228
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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