← Back to Search

Antiretroviral Drug

Antiretroviral drugs for Human Immunodeficiency Virus Infection

Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-entry, entry, day 28, day 35, day 38 (5 hours post vorinostat), day 45, day 65
Awards & highlights

Study Summary

This trial found that tamoxifen + vorinostat was better than vorinostat alone at reactivating HIV in post-menopausal women with undetectable virus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-entry, entry, day 28, day 35, day 38 (5 hours post vorinostat), day 45, day 65
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-entry, entry, day 28, day 35, day 38 (5 hours post vorinostat), day 45, day 65 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Cell-associated HIV-1 RNA in CD4+ T Cells
Proportion of Participants With New Grade 3 or Greater Adverse Events
Secondary outcome measures
Change From Baseline in Total HIV-1 DNA Levels in CD4+ T Cells
Number of Participants With HIV-1 RNA Levels (Measured by Single Copy Assay) Greater or Equal to the Lower Limit of Quantification

Side effects data

From 2023 Phase 2 trial • 31 Patients • NCT03382834
5%
Dysgeusia
5%
Thirst
5%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Tamoxifen + Vorinostat
Arm B: Vorinostat Alone

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Tamoxifen + VorinostatExperimental Treatment3 Interventions
From Day 0 to Day 38, participants will receive tamoxifen orally once a day. On Days 35 and 38, participants will receive a single dose of vorinostat orally.
Group II: Arm B: Vorinostat aloneActive Control2 Interventions
Day 0 to Day 38 will be an observation period with no tamoxifen. On Days 35 and 38, participants will receive a single dose of vorinostat orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamoxifen
2005
Completed Phase 4
~30070
Antiretroviral drugs
2018
Completed Phase 2
~40
Vorinostat
2014
Completed Phase 3
~1600

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,438 Total Patients Enrolled
Eileen Scully, MD, PhDStudy ChairJohns Hopkins University
Rajesh Gandhi, MDStudy ChairMassachusetts General Hospital (MGH) CRS
2 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

Antiretroviral drugs (Antiretroviral Drug) Clinical Trial Eligibility Overview. Trial Name: NCT03382834 — Phase 2
Human Immunodeficiency Virus Infection Research Study Groups: Arm A: Tamoxifen + Vorinostat, Arm B: Vorinostat alone
Human Immunodeficiency Virus Infection Clinical Trial 2023: Antiretroviral drugs Highlights & Side Effects. Trial Name: NCT03382834 — Phase 2
Antiretroviral drugs (Antiretroviral Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03382834 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple sites across the U.S. conducting this trial?

"This research program is enrolling participants at 14 different medical sites, including the Ucsf Hiv/Aids Crs in San Francisco, Greensboro CRS located in Greensboro and Cincinnati Clinical Research Site situated in Cincinnati."

Answered by AI

Are there other documented research investigations involving Antiretroviral drugs?

"Queen Mary University of London first explored antiretroviral drugs in 1994. Since then, there have been 267 completed studies on this subject. 97 trials are presently recruiting patients, with a considerable concentration of these investigations being conducted from San Francisco and North carolina."

Answered by AI

Has the FDA sanctioned Antiretroviral drugs for public use?

"Our team has determined that the safety of antiretroviral drugs merits a rating of 2 on our scale, as there is evidence to support their security but limited data surrounding efficacy."

Answered by AI

Is this medical research project open to individuals above the age of twenty-five?

"This trial is seeking participants who are of legal age and younger than 65 years."

Answered by AI

What is the aggregate count of participants engaging with this clinical trial?

"This medical trial has ceased searching for participants. Initially posted on April 26th 2018 and last adjusted on January 13 2022, the research is no longer recruiting. However, there are currently 485 studies actively looking to enrol patients living with HIV as well as 97 trials involving antiretroviral drugs that still require volunteers."

Answered by AI

To what end does Antiretroviral medication typically serve?

"Antiretroviral drugs are frequently prescribed to treat cancerous neoplasms, as well as progressive cutaneous t-cell lymphoma, ovarian cancer, ctage1 protein and human."

Answered by AI

Are there any opportunities for people to join this trial at the moment?

"At this time, the reported clinical trial on clinicialtrials.gov is no longer accepting patients. Initially posted in April 2018 and updated for the final time January 2022, though this study does not currently require participants there are 582 other studies actively recruiting volunteers now."

Answered by AI

Could you elucidate the criteria necessary to qualify someone for this experiment?

"To be considered for this clinical trial, applicants must have a confirmed HIV infection and fall within the 18 to 65 year old age range. Approximately 31 patients are required."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
Alabama CRS
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors
2018. "Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03382834.
~4 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top