18 and older, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)Primary· week 4 (post) compared to week 0 (pre)
Cell associated HIV nucleic acid levels were measured using a single copy assay, and numbers of cells were quantified using a polymerase chain reaction method that detects RNA.
Patient #1 HIV RNA Pre
Group
Value
95% CI
Interferon Treatment
670
Patient #1 HIV RNA Post
Group
Value
95% CI
Interferon Treatment
180
Patient #2 HIV RNA Pre
Group
Value
95% CI
Interferon Treatment
90
Patient #2 HIV RNA Post
Group
Value
95% CI
Interferon Treatment
130
Patient #3 HIV RNA Pre
Group
Value
95% CI
Interferon Treatment
810
Patient #3 HIV RNA Post
Group
Value
95% CI
Interferon Treatment
420
Patient #4 HIV RNA Pre
Group
Value
95% CI
Interferon Treatment
450
Patient #4 HIV RNA Post
Group
Value
95% CI
Interferon Treatment
390
Fold Change in Ribonucleic Acid (RNA) and Deoxyribonucleic Acid (DNA) in Human Immunodeficiency Virus Type 1 (HIV-1) Genetic Variation in Individuals Undergoing Interferon TherapySecondary· week 4 (post) and week 0 (pre)
The outcome measure is the fold change in the ratio of HIV RNA to HIV DNA. For the pre and post interferon time point, the level of HIV RNA is divided by the level of HIV DNA and this ratio of the HIV RNA/DNA pre and post interferon is calculated to yield the fold change in HIV RNA/DNA levels. Fold change does not have units.
Patient #1
Group
Value
95% CI
Interferon Treatment
0.408
Patient #2
Group
Value
95% CI
Interferon Treatment
1.44
Patient #3
Group
Value
95% CI
Interferon Treatment
0.684
Patient #4
Group
Value
95% CI
Interferon Treatment
1.12
Patient #5
Group
Value
95% CI
Interferon Treatment
2.24
Patient #6
Group
Value
95% CI
Interferon Treatment
4.37
Patient #7
Group
Value
95% CI
Interferon Treatment
1.05
Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected IndividualsSecondary· week 4 (post) compared to week 0 (pre)
The outcome measure is copies of HIV RNA per ml of plasma. HIV RNA levels are measured using a polymerase chain reaction method.
Patient #1 Pre
Group
Value
95% CI
Interferon Treatment
0.7
± 0.8
Patient #1 Post
Group
Value
95% CI
Interferon Treatment
3.8
± 1.9
Patient #2 Pre
Group
Value
95% CI
Interferon Treatment
0.2
± 0.4
Patient #2 Post
Group
Value
95% CI
Interferon Treatment
.02
± 0
Patient #3 Pre
Group
Value
95% CI
Interferon Treatment
3.8
± 1.9
Patient #3 Post
Group
Value
95% CI
Interferon Treatment
0.8
± 0.9
Patient #4 Pre
Group
Value
95% CI
Interferon Treatment
.02
± 0
Patient #4 Post
Group
Value
95% CI
Interferon Treatment
1.5
± 1.2
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adult Adverse Events.Secondary· Date consent signed to date off study, approximately 66 months and 2 days.
Here is the count of participants with serious and non-serious adverse events assessed by the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adult Adverse Events for severity (mild/moderate/severe), expectedness (expected/unexpected), and relatedness to study drug (definitely, probably, possibly, unlikely, or unrelated).
Group
Value
95% CI
Interferon Treatment
7
Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)Primary· week 4 (post) compared to week 0 (pre)
Cell associated HIV nucleic acid levels were measured using a single copy assay, and numbers of cells were quantified using a polymerase chain reaction method that detects C-C chemokine receptor type 5 (CCR5) DNA.
Patient #1 HIV DNA Pre
Group
Value
95% CI
Interferon Treatment
1200
Patient #1 HIV DNA Post
Group
Value
95% CI
Interferon Treatment
790
Patient #2 HIV DNA Pre
Group
Value
95% CI
Interferon Treatment
150
Patient #2 HIV DNA Post
Group
Value
95% CI
Interferon Treatment
150
Patient #3 HIV DNA Pre
Group
Value
95% CI
Interferon Treatment
660
Patient #3 HIV DNA Post
Group
Value
95% CI
Interferon Treatment
500
Patient #4 HIV DNA Pre
Group
Value
95% CI
Interferon Treatment
400
Patient #4 HIV DNA Post
Group
Value
95% CI
Interferon Treatment
310
Adverse events — posted to ClinicalTrials.gov
Time frame: The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Background:
* Antiretroviral therapy (ART) has been able to improve the lifespan of individuals infected with human immunodeficiency virus type 1 (HIV-1), but ART requires continuous treatment that has substantial consequences on quality of life. Recent research is attempting to determine whether this persistent infection stems from a low-level infection where new cells are continually infected with HIV, or from cells that live for a long time after infection. ART is very active against the virus in new cells, but has no effect on long-lived cells that are already infected with HIV-1 at the start of ART. As a result, new strategies may be necessary to reduce or eradicate these 'reservoir' cells.
* Interferon is a natural substance made by the body to combat virus infections, and can be made as an injectable drug known as PEGINTRON. Researchers are interested in determining whether PEGINTRON therapy will also reduce the residual low levels of HIV in patients who are already taking ART.
Objectives:
\- To evaluate the effectiveness of PEGINTRON injections on HIV levels in participants currently undergoing antiretroviral therapy.
Eligibility:
\- Individuals at least 18 years of age who have been diagnosed with HIV, are currently undergoing antiretroviral therapy, and have maintained HIV virus blood counts that are not detectable by current commercial tests for at least 12 months before the start of the study.
Design:
* This study will involve separate screening and treatment processes.
* Participants will be screened with a physical examination and medical history, including blood and urine samples. The screening analysis to determine study eligibility will take several weeks. Participants will have apheresis to provide sufficient numbers of blood cells for evaluation by the study researchers.
* Eligible participants will begin a 4-week course of PEGINTRON injections using the standard dose of PEGINTRON that is approved for treatment of chronic hepatitis C. Participants will have weekly injections and have frequent blood tests to measure HIV virus levels.
* Participants who experience problems in maintaining safe numbers of white blood cells during the study may receive injections of filgrastim to increase their white blood cell count.
* After the 4 weeks of treatment, participants will return for additional blood tests on study days 28, 35, 42, 49, 56, and 84, and Weeks 16, 24, 36, and 48 (i.e., through the end of 1 year after the start of the study).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06900829 — #AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-i
· NA
· recruiting
NCT06908252 — MAPS PrEP Van Study
· Phase 4
· recruiting
NCT07042945 — MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003)
· Phase 1
· recruiting
NCT06716450 — Multiplo Tp/HIV Self-Test
· NA
· recruiting
NCT07086989 — Cardiovascular Risk in Children With Chronic Conditions Study
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 23 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01295515.