A Phase 2 interventional study of Tamoxifen and Vorinostat in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 15 sites in 2 countries. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
This study evaluated the effects of tamoxifen exposure in combination with vorinostat on viral reactivation among HIV-1 infected post-menopausal women with virologic suppression on antiretroviral therapy (ART), when compared to vorinostat alone.
The selective estrogen receptor modulator (SERM) tamoxifen may enhance the ability of the histone deacetylase inhibitor (HDACi) vorinostat to reverse HIV-1 latency. This study evaluated the safety of tamoxifen therapy combined with vorinostat and the effectiveness of this combination on latent virus reactivation in HIV-1 infected post-menopausal women with virologic suppression on antiretroviral therapy, when compared to vorinostat alone.
The study was conducted in two steps. During Step 1, the study enrolled women with HIV into two groups. Arm A received tamoxifen daily for 38 days, plus a single dose of vorinostat on Days 35 and 38. Arm B had a 38-day observation period with no tamoxifen, plus a single dose of vorinostat on Days 35 and 38. All participants continued to take ART drugs prescribed by their doctors. ART drugs were not be provided by the study.
Study visits during Step 1 occurred at Days 0, 28, 35, 38, 45, and 65. Study visits could include physical examinations, blood collection, electrocardiograms, and adherence assessments.
During Step 2, all participants were followed for 240 additional weeks for annual long-term safety follow-up. These visits were conducted by phone and collected information from participants on vital status and any new cancer diagnoses.
Step 1 and Step 2 have been completed and this results submission pertains to both.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 31 is below the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tamoxifen · Drug: Vorinostat · Drug: Antiretroviral drugs
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.
Drug: Vorinostat · Drug: Antiretroviral drugs
20 mg orally
400 mg orally
Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.
Proportion of Participants With New Grade 3 or Greater Adverse Events
Proportion of participants with new Grade 3 or greater adverse events that are considered definitely, probably, or possibly related to study treatment (as judged by the core protocol team). The DAIDS AE Grading Table (corrected Version 2.1, July 2017) was used.
Time frame: Measured from study entry through Day 65
Change From Baseline in Cell-associated HIV-1 RNA in CD4+ T Cells
Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value of Cell-associated HIV-1 RNA on Day 38 (5 hours post vorinostat) minus the value at baseline.
Time frame: Pre-entry, entry, and Day 38
Number of Participants With HIV-1 RNA Levels (Measured by Single Copy Assay) Greater or Equal to the Lower Limit of Quantification
Number of participants with HIV-1 RNA levels measured by single copy assay (SCA) greater or equal to the lower limit of quantification (LOQ). The lower limit of quantification for this study was 0.47 copies/mL.
Time frame: Pre-entry, entry, Day 28, Day 35, Day 38 (5 hours post vorinostat), Day 45, Day 65
Change From Baseline in Total HIV-1 DNA Levels in CD4+ T Cells
Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value of Total HIV-1 DNA on Day 38 (5 hours post vorinostat) minus the value at baseline.
Time frame: Pre-entry, entry, and Day 38
| Milestone | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone |
|---|---|---|
| Started | 21 | 10 |
| Completed | 21 | 9 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Milestone | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone |
|---|---|---|
| Started | 21 | 9 |
| Completed | 17 | 7 |
| Not completed | 4 | 2 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Site terminated by sponsor | 1 | 0 |
Proportion of participants with new Grade 3 or greater adverse events that are considered definitely, probably, or possibly related to study treatment (as judged by the core protocol team). The DAIDS AE Grading Table (corrected Version 2.1, July 2017) was used.
| proportion of participants | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone |
|---|---|---|
| Proportion of Participants With New Grade 3 or Greater Adverse Events | 0 (0 to 0.13) | 0 (0 to 0.28) |
Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value of Cell-associated HIV-1 RNA on Day 38 (5 hours post vorinostat) minus the value at baseline.
| log10 copies/million CD4 cells | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone |
|---|---|---|
| Change From Baseline in Cell-associated HIV-1 RNA in CD4+ T Cells | 0.06 (-0.24 to 0.36) | 0.17 (-0.15 to 0.50) |
Number of participants with HIV-1 RNA levels measured by single copy assay (SCA) greater or equal to the lower limit of quantification (LOQ). The lower limit of quantification for this study was 0.47 copies/mL.
| Participants | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone |
|---|---|---|
| Pre-entry SCA >= LOQ | 10 | 6 |
| Entry SCA >=LOQ | 9 | 3 |
| Day 28 SCA >=LOQ | 11 | 4 |
| Day 35 SCA >=LOQ | 11 | 5 |
| Day 38 SCA >=LOQ | 7 | 5 |
| Day 45 SCA >=LOQ | 9 | 4 |
| Day 65 SCA >=LOQ | 10 | 5 |
Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value of Total HIV-1 DNA on Day 38 (5 hours post vorinostat) minus the value at baseline.
| log10 copies/million CD4 cells | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone |
|---|---|---|
| Change From Baseline in Total HIV-1 DNA Levels in CD4+ T Cells | 0 (-0.12 to 0.13) | -0.04 (-0.33 to 0.25) |
Collected over From study entry to end of study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Tamoxifen + Vorinostat | 1/21 (4.8%) | 0/21 (0%) | 3/21 (14.3%) |
| Arm B: Vorinostat Alone | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Event | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone |
|---|---|---|
| HyperglycaemiaMetabolism and nutrition disorders | 1/21 | 0/10 |
| DysgeusiaNervous system disorders | 1/21 | 0/10 |
| ThirstGeneral disorders | 1/21 | 0/10 |
| Metastatic squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/21 | 0/10 |
All enrolled participants
| Age, Continuous(years) | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone | Total |
|---|---|---|---|
| Median | 57 (54 to 61) | 55 (51 to 59) | 57 (53 to 60) |
| Age, Customized(Participants) | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone | Total |
|---|---|---|---|
| Age categorized — < 50 years | 2 | 1 | 3 |
| Age categorized — 50 - 59 years | 11 | 7 | 18 |
| Age categorized — >= 60 years | 8 | 2 | 10 |
| Sex: Female, Male(Participants) | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone | Total |
|---|---|---|---|
| Female | 21 | 10 | 31 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 2 | 6 |
| Not Hispanic or Latino | 17 | 8 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 7 | 18 |
| White | 9 | 3 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone | Total |
|---|---|---|---|
| Puerto Rico | 1 | 0 | 1 |
| United States | 20 | 10 | 30 |
| Baseline Cell-associated HIV-1 RNA(log10 copies/million CD4 cells) | Arm A: Tamoxifen + Vorinostat | Arm B: Vorinostat Alone | Total |
|---|---|---|---|
| Median | 1.81 (1.38 to 2.49) | 2.5 (2.01 to 3.15) | 2.17 (1.56 to 2.69) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by the NIH.
Access criteria: With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group. For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group. By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://submit.mis.s-3.net/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data."
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tamoxifen
National Institute of Allergy and Infectious Diseases (NIAID) →