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Evaluating the Safety and Efficacy of Romidepsin in Combination With Antiretroviral Therapy in HIV-Infected Adults With Suppressed Viral Load

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01933594
First received: August 28, 2013
Last updated: February 14, 2017
Last verified: February 2017

August 28, 2013
Not Provided
February 2014
August 2017   (Final data collection date for primary outcome measure)
  • Occurrence of Grade 3 or higher adverse events (AEs) [ Time Frame: Measured through 28 days after the administration of RMD or placebo ]
    Including signs/symptoms, lab toxicities, and /or clinical events that is probably, possibly, or definitely related to study treatment (as judged by the core team, blinded to treatment arm)
  • Change in plasma HIV-1 RNA levels from baseline (average of pre-entry and entry values) as detected by single copy assay [ Time Frame: Measured through 48 hours (average) after the single administration of RMD or placebo in Cohorts 1-3 ]
  • Change in cell-associated HIV-1 RNA levels in resting CD4 T cells [ Time Frame: Measured through 24 hours after the single administration of RMD or placebo in Cohorts 1-3 ]
  • Change in cell-associated HIV-1 RNA levels in resting CD4 T-cells [ Time Frame: Measured through participant's last study visit, at 24 weeks to 48 weeks in Cohort 4 ]
  • Change in total virus recovery [ Time Frame: Measured through participant's last study visit, at 24 weeks to 48 weeks in Cohort 4 ]
  • Occurrence of Grade 3 or higher adverse events (AEs) [ Time Frame: Measured through 28 days after the administration of RMD or placebo ]
    Including signs/symptoms, lab toxicities, and /or clinical events that is probably, possibly or definitely related to study treatment (as judged by the core team, blinded to treatment arm)
  • Change in plasma HIV-1 RNA levels from baseline (average of pre-entry and entry values) as detected by single copy assay [ Time Frame: Measured through 48 hours (average) after the administration of RMD or placebo ]
  • Change in cell-associated HIV-1 RNA levels in resting CD4+ T-cells [ Time Frame: Measured through 24 hours after the administration of RMD or placebo ]
No Changes Posted
  • Changes in plasma HIV-1 RNA levels as detected by single copy assay [ Time Frame: Measured through 28 days after the single administration of RMD and placebo in Cohorts 1-3 ]
  • Changes in plasma HIV-1 RNA levels as detected by single copy assay [ Time Frame: Measured through 28 days after the last administration of RMD and placebo in Cohort 4 ]
  • Change in cell-associated HIV-1 RNA levels in resting CD4 T cells [ Time Frame: Measured through 14 days after the administration of RMD or placebo ]
  • Changes in cell-associated HIV-1 RNA levels in total CD4 T cells [ Time Frame: Measured through 28 days after the single administration of RMD or placebo in Cohorts 1-3 ]
  • Changes in cell-associated HIV-1 RNA levels in total CD4 T cells [ Time Frame: Measured through 28 days after the last administration of RMD or placebo in Cohort 4 ]
  • Changes in histone acetylation in total CD4 T cells by flow cytometry [ Time Frame: Measured through 14 days after the single administration of RMD or placebo in Cohorts 1-3 ]
  • Changes in histone acetylation in total CD4 T cells by flow cytometry [ Time Frame: Measured through 14 days after the last administration of RMD or placebo in Cohort 4 ]
  • Changes in total HIV-1 DNA and 2-long terminal repeat (LTR) circles in resting or total CD4 T cells [ Time Frame: Measured through 28 days after the single administration of RMD or placebo in Cohorts 1-3 ]
  • Changes in total HIV-1 DNA and 2-long terminal repeat (LTR) circles in resting or total CD4 T cells [ Time Frame: Measured through 28 days after the last administration of RMD or placebo in Cohort 4 ]
  • PK parameters (area under the curve [AUC], maximum concentration [Cmax], and minimum concentration [Cmin]) for RMD and co-administered antiretroviral drugs (EFV, DTG, or RAL) [ Time Frame: Measured through 24 hours after the administration of RMD or placebo ]
  • Number of participants in Cohorts 1-3 with HIV-1 RNA levels greater than or equal to 200 copies [ Time Frame: Measured through 7 days after the administration of RMD or placebo ]
  • Percent of participants in Cohorts 1-3 with HIV-1 RNA levels greater than or equal to 200 copies [ Time Frame: Measured through 7 days after the administration of RMD or placebo ]
  • Number of participants in Cohort 4 with HIV-1 RNA levels greater than or equal to 200 copies/mL [ Time Frame: Measured through participant's last study visit, at 24 weeks to 48 weeks ]
  • Percent of participants in Cohort 4 with HIV-1 RNA levels greater than or equal to 200 copies/mL [ Time Frame: Measured through participant's last study visit, at 24 weeks to 48 weeks ]
  • All reported Grade 2 through 4 AEs [ Time Frame: Measured through participant's last study visit, at 4 weeks to 48 weeks ]
  • Changes in plasma HIV-1 RNA levels as detected by single copy assay [ Time Frame: Measured through 28 days after the administration of RMD and placebo ]
  • Change in cell-associated HIV-1 RNA levels in resting CD4+ T-cells [ Time Frame: Measured through 14 days after the administration of RMD or placebo ]
  • Changes in cell-associated HIV-1 RNA levels in total CD4+ T-cells [ Time Frame: Measured through 28 days after the administration of RMD or placebo ]
  • Changes in histone acetylation in total CD4+ T-cells by flow cytometry [ Time Frame: Measured through 14 days after the administration of RMD or placebo ]
  • Changes in total HIV-1 DNA and 2-long terminal repeat (LTR) circles in resting or total CD4+ T-cells [ Time Frame: Measured through 28 days after the administration of RMD or placebo ]
  • PK parameters (area under the curve [AUC], maximum concentration [Cmax], and minimum concentration [Cmin]) for RMD and co-administered antiretroviral drugs (EFV or RAL). [ Time Frame: Measured through 24 hours after the administration of RMD or placebo ]
  • Number/percent of participants with HIV-1 RNA levels greater than 200 copies [ Time Frame: Measured through 7 days after the administration of RMD or placebo ]
  • All reported Grade 2 through 4 AEs [ Time Frame: Measured through 28 or 56 days after the administration of RMD or placebo ]
    Whether this is measured through 28 or 56 days after the administration of RMD or placebo depends on when the participant's last study visit is.
Not Provided
Not Provided
 
Evaluating the Safety and Efficacy of Romidepsin in Combination With Antiretroviral Therapy in HIV-Infected Adults With Suppressed Viral Load
A Phase I/II Study of Romidepsin in HIV-Infected Adults With Suppressed Viremia on Antiretroviral Therapy to Assess Safety, Tolerability, and Activation of HIV-1 Expression
Antiretroviral therapy (ART) can reduce HIV to very low levels in the blood, but it cannot cure HIV infection because a small amount of virus remains in cells as a hidden (latent) form. The purpose of this study is to evaluate the safety and efficacy of single dose and multiple dose administration of romidepsin (RMD) in HIV-infected adults.

A major challenge in eradicating HIV-1 infection is the persistence of virus in long-lived cells, such as latently infected memory CD4 T cells. One approach for eliminating the HIV-1 reservoir is to activate viral replication in these latently infected CD4 T cells by targeting cellular mechanisms that repress proviral transcription. Histone deacetylase inhibitors (HDACis), such as RMD, induce HIV-1 expression by increasing acetylation and facilitating transcriptional activation of HIV-1. RMD administered in combination with ART may serve as an important component of a strategy to eradicate the HIV-1 latent reservoir. The purpose of this study is to evaluate the safety and efficacy of single dose and multiple dose administration of RMD in HIV-infected adults.

Participants will be sequentially enrolled into four cohorts and randomly assigned to receive either RMD or placebo. The cohorts will differ in the dose of RMD given. Participants in Cohorts 1, 2, and 3 will have one intravenous (IV) infusion of RMD or placebo at Day 0. Participants in Cohort 4 will have four IV infusions of RMD or placebo at Days 0, 14, 28, and 42.

For participants in Cohorts 1, 2, and 3, study duration is 4 weeks. For participants in Cohort 4, study duration is a minimum of 24 weeks and a maximum of 48 weeks.

Participants will attend several study visits, which may include a physical examination, blood and urine collection, pharmacokinetic (PK) sampling, and an electrocardiogram (ECG).

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
HIV Infections
  • Drug: Romidepsin
    RMD will be administered over 4 hours via an intravenous (IV) catheter.
    Other Names:
    • RMD
    • Istodax
  • Drug: Placebo for RMD: 0.9% sodium chloride for injection
    Placebo for RMD will be administered over 4 hours via an IV catheter.
    Other Name: 0.9% NaCl
  • Experimental: Cohort 1-Arm 1A (RMD)
    Participants in Cohort 1, Arm 1A will receive RMD intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of RMD will be 0.5 mg/m^2, with total dose based on the participant's body surface area (BSA), which is determined by participant's height and weight.
    Intervention: Drug: Romidepsin
  • Placebo Comparator: Cohort 1-Arm 1B (Placebo for RMD)
    Participants in Cohort 1, Arm 1B will receive 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of sodium chloride for injection placebo will be 0.5 mg/m^2, with total dose based on the participant's BSA, which will be determined by weight and height.
    Intervention: Drug: Placebo for RMD: 0.9% sodium chloride for injection
  • Experimental: Cohort 2-Arm 2A (RMD)
    Participants in Cohort 2, Arm 2A will receive RMD IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of RMD will be 2 mg/m^2, with total dose based on the participant's BSA, which is determined by participant's height and weight.
    Intervention: Drug: Romidepsin
  • Placebo Comparator: Cohort 2-Arm 2B (Placebo for RMD)
    Participants in Cohort 2, Arm 2B will receive 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of sodium chloride for injection placebo will be 2 mg/m^2, with total dose based on the participant's BSA, which will be determined by weight and height.
    Intervention: Drug: Placebo for RMD: 0.9% sodium chloride for injection
  • Experimental: Cohort 3-Arm 3A (RMD)
    Participants in Cohort 3, Arm 3A will receive RMD IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of RMD will be 5 mg/m^2, with total dose based on the participant's BSA, which is determined by participant's height and weight.
    Intervention: Drug: Romidepsin
  • Placebo Comparator: Cohort 3-Arm 3B (Placebo for RMD)
    Participants in Cohort 3, Arm 3B will receive 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of sodium chloride for injection placebo will be 5 mg/m^2, with total dose based on the participant's BSA, which will be determined by weight and height.
    Intervention: Drug: Placebo for RMD: 0.9% sodium chloride for injection
  • Experimental: Cohort 4-Arm 4A (RMD)
    Participants in Cohort 4, Arm 4A will receive RMD IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits. Dose of RMD will be 5 mg/m^2, with total dose based on the participant's BSA, which is determined by participant's height and weight.
    Intervention: Drug: Romidepsin
  • Placebo Comparator: Cohort 4-Arm 4B (Placebo for RMD)
    Participants in Cohort 4, Arm 4B will receive 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits. Dose of sodium chloride for injection placebo will be 5 mg/m^2, with total dose based on the participant's BSA, which is determined by participant's height and weight.
    Intervention: Drug: Placebo for RMD: 0.9% sodium chloride for injection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
August 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria: Cohorts 1, 2, & 3

  • HIV-1 infection, documented by any licensed rapid HIV test or HIV E/CIA test kit at any time prior to study entry & confirmed by a licensed Western blot or a 2nd antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA
  • Receiving 2 (or more) nucleoside or nucleotide reverse transcriptase inhibitors with raltegravir, dolutegravir, or efavirenz for at least 90 days prior to study entry with no intention to change for the duration of the study
  • Documentation of at least 2 historical HIV-1 RNA measurements <50 copies/mL while on ART obtained by standard ultrasensitive assay. Documentation of the 1st measurement must be from a result obtained between 365-91 days, inclusive, prior to study entry. Documentation of the 2nd measurement must be from a result obtained between 730-366 days, inclusive, prior to study entry. In addition, there must be no HIV-1 RNA values ≥50 copies/mL for at least 365 days prior to study entry.
  • CD4 cell count ≥300 cells/mm^3 obtained within 90-50 days prior to study entry at any US laboratory that has a CLIA certification or equivalent
  • HIV-1 RNA level of <50 copies/mL obtained by standard ultrasensitive assay within 90-50 days prior to study entry
  • HIV-1 RNA level of ≥0.4 copies/mL obtained by SCA within 90-50 days prior to study entry. This result must be available prior to the pre-entry visit
  • The following laboratory values obtained within 21-0 days prior to study entry by any laboratory that has a CLIA certification or equivalent

    • ANC ≥1500 cells/mm^3
    • Hemoglobin ≥12.0 g/dL for men & >11.0 g/dL for women
    • Platelet count ≥120,000/mm^3
  • The following laboratory values obtained within 21-7 days prior to study entry by any laboratory that has a CLIA certification or equivalent

    • CrCl ≥60 mL/min
    • Potassium & magnesium within normal limits
    • AST (SGOT) <2.0 x ULN
    • ALT (SGPT) <2.0 x ULN
    • Alkaline phosphatase <2.0 x ULN
    • Total bilirubin <2.5 x ULN
  • HCV antibody negative result within 90-50 days prior to study entry or, for study candidates who are HCV antibody positive (based on testing performed at any time prior to study entry), a negative HCV RNA result obtained within 90-50 days prior to study entry
  • Negative HBsAg result obtained within 90-50 days prior to study entry or a positive HBsAb result at any time prior to study entry
  • For females of reproductive potential, negative serum or urine pregnancy test (latter with sensitivity of ≤25 mIU/mL) at the screening visit, pre-entry visit within 21-7 days prior to study entry, & at entry prior to romidepsin infusion, by any US laboratory that has a CLIA certification or equivalent
  • Female candidates of reproductive potential must refrain from participating in active attempts to become pregnant, &, if participating in sexual activity that could lead to pregnancy, must agree to use at least 2 reliable forms of contraception that are non-estrogen based. All female participants of reproductive potential must be instructed to use contraceptives for 6 months/180 days after completing RMD or placebo infusion
  • Karnofsky performance score ≥80 within 21-7 days prior to study entry
  • Ability & willingness to provide written informed consent
  • Investigator anticipates that a fully active alternative ART regimen could be constructed in the event of virologic failure on the current ART regimen

Exclusion Criteria: Cohorts 1, 2, & 3

  • History of or current malignancy requiring cytotoxic therapy
  • Bacterial, fungal, or viral infection (other than HIV) requiring systemic therapy within 30 days prior to entry
  • History of or current CMV end organ disease (eg, retinitis)
  • History of or current AIDS-related syndromes or symptoms that pose a perceived excessive risk for study drug-related morbidity, as determined by the investigator
  • Chronic, acute, or recurrent infections that are current & serious in the opinion of the investigator & for which the participant has not completed at least 14 consecutive days of therapy within 30 days prior to study entry and/or is not clinically stable
  • Active autoimmune disorders including but not limited to: inflammatory bowel diseases, scleroderma, severe psoriasis as determined by the investigator, systemic lupus erythematosus, rheumatoid arthritis & optic neuritis
  • History of seizure disorders
  • History of anticonvulsant use within 60 days prior to study entry
  • History of MI within 6 months prior to study entry, history of QTc prolongation (defined as ECG with QTc intervals >450 ms) at any time prior to study entry, NYHA class III or IV heart failure at any time prior to study entry, or family history of prolonged QTc syndrome
  • Breastfeeding
  • Use of immunomodulators (eg, interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry
  • Any vaccination within 30 days prior to entry or intent to receive an elective vaccination (eg, flu shot, hepatitis A or B vaccine) during the course of the study
  • Intent to use cytokines (e.g., IL-2 or IL-12) during the course of the study. Prior administration of cytokines is not an exclusion criterion; however, at least 60 days between the most recent cycle of any cytokine and study entry is required
  • Within 60 days prior to study entry, use of systemic azole antifungals (voriconazole, itraconazole, ketoconazole); dexamethasone; macrolide antibiotics (azithromycin, clarithromycin, erythromycin); ARVs that are inhibitors of, or are metabolized by, CYP3A4 (atazanavir, ritonavir, nelfinavir, indinavir, saquinavir, darunavir, lopinavir, rilpivirine, maraviroc); cobicistat; warfarin; nefazodone; rifamycins (rifabutin, rifampin, rifapentine); St. John's Wort; carbamazepine; phenytoin; phenobarbital; amiodarone; dofetilide; pimozide; procainamide; quinidine; sotalol; & birth control products containing estrogen; drugs that are p-glycoprotein inhibitors; & drugs that prolong the QTc interval with a risk of Torsades de Pointes
  • Known allergy, sensitivity, or any hypersensitivity to components of RMD or its formulation
  • Use of histone deacetylase inhibitors (eg, vorinostat, valproic acid) at any time prior to study entry
  • Active illicit drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
  • Acute or serious illness requiring systemic treatment and/or hospitalization that is not resolved within 30 days prior to entry
  • Psychosocial conditions that would prevent study compliance and follow-up, as determined by the investigator
  • Documented opportunistic infections within 60 days prior to entry

Inclusion Criteria: Cohort 4, Step 1

  • HIV-1 infection, documented by any licensed rapid HIV test or HIV E/CIA test kit at any time prior to study entry & confirmed by a licensed Western blot or a 2nd antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA
  • Receiving 2 or more nucleoside or nucleotide reverse transcriptase inhibitors with raltegravir or dolutegravir for at least 90 days prior to study entry with no intention to change for the duration of the study
  • Documentation of at least 2 historical HIV-1 RNA measurements <50 copies/mL while on ART obtained by standard ultrasensitive assay. Documentation of the first measurement must be from a result obtained between 365-61 days, inclusive, prior to study entry. Documentation of the second measurement must be from a result obtained between 730-366 days, inclusive, prior to study entry. In addition, there must be no HIV-1 RNA values ≥50 copies/mL for at least 365 days prior to study entry
  • CD4 cell count ≥300 cells/mm^3 obtained between 36-60 days prior to study entry (screening visit) at any US laboratory that has a CLIA certification or equivalent
  • HIV-1 RNA level of <50 copies/mL obtained by standard ultrasensitive assay at screening (between 36-60 days prior to study entry)
  • The following laboratory values obtained at pre-entry (between 3-14 days prior to study entry) by any laboratory that has a CLIA certification or equivalent

    • ANC ≥1500 cells/mm^3
    • Hemoglobin ≥12.0 g/dL for men & >11.0 g/dL for women
    • Platelet count ≥120,000/mm^3
    • CrCl ≥60 mL/min
    • Potassium & magnesium within normal limits
    • AST (SGOT) <2.0 x ULN
    • ALT (SGPT) <2.0 x ULN
    • Alkaline phosphatase <2.0 x ULN
    • Total bilirubin <2.5 x ULN
  • HCV antibody negative result at screening (between 36-60 days prior to study entry) or, for study candidates who are HCV antibody positive (based on testing performed at any time prior to study entry), a negative HCV RNA result obtained at screening
  • Negative HBsAg result obtained at screening (between 36-60 days prior to study entry) or a positive HBsAb result at any time prior to study entry
  • For females of reproductive potential, negative urine pregnancy test (with a sensitivity of ≤25 mIU/mL) at screening (between 36-60 days prior to study entry), at pre-entry (between 3-14 days prior to study entry), & at entry prior to infusion, by any US laboratory that has a CLIA certification or equivalent
  • Female candidates of reproductive potential must refrain from participating in active attempts to become pregnant, &, if participating in sexual activity that could lead to pregnancy, must agree to use at least 2 reliable forms of contraception that are non-estrogen based. All participants of reproductive potential will be instructed to use contraceptives for 6 months or 180 days after completing RMD/placebo infusion
  • Karnofsky performance score ≥80 at pre-entry (between 3-14 days prior to study entry)
  • Ability & willingness to provide written informed consent
  • Investigator anticipates that a fully active alternative ART regimen could be constructed in the event of virologic failure on the current ART regimen

Exclusion Criteria: Cohort 4, Step 1

  • History of or current malignancy requiring cytotoxic therapy
  • Bacterial, fungal or viral infection (other than HIV) requiring systemic therapy within 30 days prior to entry
  • History of or current CMV end organ disease (eg, retinitis)
  • History of or current AIDS-related syndromes or symptoms that pose a perceived excessive risk for study drug-related morbidity, as determined by the investigator
  • Chronic, acute, or recurrent infections that are current & serious, in the opinion of the investigator, for which the participant has not completed at least 14 consecutive days of therapy within 30 days prior to study entry and/or is not clinically stable
  • Active autoimmune disorders including but not limited to inflammatory bowel diseases, scleroderma, severe psoriasis as determined by the investigator, systemic lupus erythematosus, rheumatoid arthritis, & optic neuritis
  • History of seizure disorders
  • History of anticonvulsant use within 60 days prior to study entry
  • History of MI within 6 months prior to study entry, history of QTc prolongation (defined as ECG with QTc intervals >450 ms) at any time prior to study entry, NYHA class III or IV heart failure at any time prior to study entry, or family history of prolonged QTc syndrome
  • Breastfeeding
  • Use of immunomodulators (eg, interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry
  • Any vaccination within 30 days prior to entry or intent to receive an elective vaccination (eg, flu shot, hepatitis A or B vaccine) during the course of the study
  • Intent to use cytokines (eg, IL-2 or IL-12) during the course of the study
  • Within 60 days prior to study entry, use of systemic azole antifungals (voriconazole, itraconazole, ketoconazole), dexamethasone, macrolide antibiotics (azithromycin, clarithromycin, erythromycin), antiretrovirals that are inhibitors of, or are metabolized by CYP3A4 (atazanavir, ritonavir, nelfinavir, indinavir, saquinavir, darunavir, lopinavir, rilpivirine, maraviroc), cobicistat, warfarin, nefazodone, rifamycins (rifabutin, rifampin, rifapentine), St. John's Wort, carbamazepine, phenytoin, phenobarbital, amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, & birth control products containing estrogen, drugs that are p-glycoprotein inhibitors, & drugs that prolong the QTc interval with a risk of Torsades de Pointes
  • Known allergy/sensitivity or any hypersensitivity to components of RMD or its formulation
  • Use of histone deacetylase inhibitors (eg, vorinostat, valproic acid) at any time prior to study entry
  • Active illicit drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
  • Acute or serious illness requiring systemic treatment and/or hospitalization that is not resolved within 30 days prior to entry
  • Psychosocial conditions that would prevent study compliance & follow-up as determined by the investigator
  • Documented opportunistic infections within 60 days prior to entry
  • Use of any of the medications listed in the Prohibited Medications table in the protocol

See the protocol for Inclusion and Exclusion Criteria for Cohort 4, Steps 2, 3, and 4.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
United States
 
 
NCT01933594
A5315, 11892, ACTG 5315
Yes
Not Provided
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: John Mellors, MD University of Pittsburgh
Study Chair: Deborah McMahon, MD University of Pittsburgh
National Institute of Allergy and Infectious Diseases (NIAID)
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP