HIV/AIDS Clinical Trial
Official title:
Optimal Management of HIV Infected Adults at Risk for Kidney Complications in Nigeria
Verified date | April 2024 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, the Investigators plan to determine the optimal means to prevent or slow the progression of kidney disease among genetically at-risk northern Nigerian HIV-infected adults. Based on data from studies of diabetic kidney disease that used medications that block the renin angiotensin aldosterone system (RAAS), we plan to evaluate whether or not RAAS inhibition (using a widely available medication that blocks RAAS) in HIV-infected adults produces similarly promising results.
Status | Suspended |
Enrollment | 280 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion criteria: - Participated in Study Aim 1 - 18-70 years of age - HIV-positive (as documented by HIV-1 ELISA testing) - On ART for a minimum of six (6) months AND having a suppressed plasma viral load result (< 20 copies/mL) within the past 6 months - Average uACR between 30-300 mg/g (based on 2 uACRs [first morning voids], with the second obtained 4-8 weeks after the first specimen)(NOTE: All aim 1 screened patients having a uACR value > 300 mg/g will undergo urine dipstick analysis for aim 2 eligibility, and if their urine dipstick results reveals = 2+ protein, then they will be considered ineligible (no additional uACR testing will be necessary to determine eligibility) - eGFR = >60 ml/min/1.73m2 (using CKD-EPI-Cr-CyC equation) AND - If female, non-pregnant (documentation of negative urine pregnancy test) and not breastfeeding/lactating Exclusion criteria: - Pregnant or currently breastfeeding - eGFR of <60 ml/min/1.73m2 (using CKD-EPI-Cr-CyC equation) - Average uACR > 300 mg/g (based on 2 uACRs [first morning voids], with the second obtained 4-8 weeks after the first specimen) - K+ >5.0 meEq/L or reasons to be concerned about hyperkalemia - Known history of Diabetes diabetes mellitus (would qualify for treatment with an ACEi/ARB) - Poorly controlled hypertension (=3 BP readings >160/110 in past 3 6 months) - Known history of Congestive congestive heart failure (chronic) - Average uACR (calculated on values obtained from 2 successive measures 4-8 weeks apart) of < 30 mg/g OR > 300 mg/g - Relative symptomatic hypotension (BP <90/60) - Currently receiving an ACEi and/or ARB; OR - Lack of suitability as a study candidate (i.e. active substance use disorder, active use of potentially nephrotoxic medication(s) (i.e. traditional medicines, etc.) and/or consistent alcohol, drug, and/or traditional medication use, and/or history of poor compliance (i.e. multiple missed scheduled clinic appointments, etc.) |
Country | Name | City | State |
---|---|---|---|
Nigeria | Aminu Kano Teaching Hospital | Kano |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | Aminu Kano Teaching Hospital, Brigham and Women's Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), SAIC-Frederick, Inc. |
Nigeria,
Aliyu MH, Wudil UJ, Ingles DJ, Shepherd BE, Gong W, Musa BM, Muhammad H, Sani MU, Abdu A, Nalado AM, Atanda A, Ahonkhai AA, Ikizler TA, Winkler CA, Kopp JB, Kimmel PL, Wester CW. Optimal management of HIV- positive adults at risk for kidney disease in Nigeria (Renal Risk Reduction "R3" Trial): protocol and study design. Trials. 2019 Jun 10;20(1):341. doi: 10.1186/s13063-019-3436-y. — View Citation
Wudil UJ, Aliyu MH, Prigmore HL, Ingles DJ, Ahonkhai AA, Musa BM, Muhammad H, Sani MU, Nalado AM, Abdu A, Abdussalam K, Shepherd BE, Dankishiya FS, Burgner AM, Ikizler TA, Wyatt CM, Kopp JB, Kimmel PL, Winkler CA, Wester CW. Apolipoprotein-1 risk variants and associated kidney phenotypes in an adult HIV cohort in Nigeria. Kidney Int. 2021 Jul;100(1):146-154. doi: 10.1016/j.kint.2021.03.038. Epub 2021 Apr 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Regression from microalbuminuria (uACR 30-300) to normoalbuminuria (uACR < 30 mg/g) by study arm | Reduction/improvement in degree/grade of albuminuria | 2 years | |
Primary | Progression from microalbuminuria (uACR 30-300) to macroalbuminuria (uACR > 300 mg/g) by study arm | Progression/worsening in degree/grade of albuminuria | 2 years | |
Primary | Mean change in urinary albumin to creatinine ratio (uACR) | Mean change in urinary albumin excretion | 2 years | |
Secondary | Doubling of serum creatinine from baseline | Worsening renal function (as measured by serum creatinine) | 2 years | |
Secondary | All-cause mortality | Survival | 2 years | |
Secondary | Proportion experiencing a 40% decline in eGFR | Proportion with 40% decline in eGFR (measured using CKD-EPI-Cr-CyC equation) | 2 years | |
Secondary | Mean change in eGFR over time | Mean change in eGFR (measured using CKD-EPI-Cr-CyC equation) | 2 years | |
Secondary | Change in clinical/performance status as ascertained via World Health Organization Quality of Life HIV (WHOQOL-HIV) scale | WHOQOL-HIV scale evaluates quality of life based on physical, psychological, social, environmental, and spiritual domains, as well as level of independence. We will use the 31-question version, with each question rated on a 5-point Likert scale. Scores of questions within each domain are averaged to get domain score, and final score is mean of domain scores multiplied by 4. Final score ranges from 4 to 20, with 20 being optimal. | baseline, 1 year, 2 years | |
Secondary | Change in clinical/performance status as ascertained via Karnofsky Performance Score | Karnofsky Performance Score measures change in clinical/performance status with values ranging from 0 to 100, where 100 is perfect health and 0 is death. | baseline, 1 year, 2 years |
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