Doravirine/Islatravir for HIV

(DELILAH Trial)

Not yet recruiting at 1 trial location
JE
AS
Overseen ByArezou S Akha
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: The University of Texas Health Science Center, Houston
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new HIV treatment using two drugs, Doravirine and Islatravir, to determine if they can slow biological aging in people with HIV. Researchers aim to compare this treatment to current standard therapies to assess its effectiveness and potential side effects. Suitable candidates for the trial include those living with HIV-1 who have been on antiretroviral therapy for at least two years and have shown stable virus levels (low HIV RNA) in recent tests. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown promising safety results for the combination of doravirine and islatravir. Research indicates that patients tolerate the treatment well. For example, one study found that the safety and tolerability of doravirine/islatravir were similar to other HIV treatments over 96 weeks, with no major differences in side effects. This suggests the combination is relatively safe to use. Although some patients stopped treatment in another study, these discontinuations were not necessarily due to serious side effects. Overall, previous research has generally found the doravirine/islatravir combination to be well-received in terms of safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Doravirine and Islatravir for HIV because they offer a fresh approach to treatment. Unlike standard therapies that typically combine multiple drugs, Islatravir is a novel nucleoside reverse transcriptase translocation inhibitor (NRTTI) with a unique mechanism that blocks the virus from copying itself. Doravirine, on the other hand, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that complements this action by further inhibiting viral replication. Together, these drugs could simplify treatment regimens and improve adherence, potentially enhancing the quality of life for people living with HIV.

What evidence suggests that this trial's treatments could be effective for HIV?

This trial will evaluate the effectiveness of doravirine and islatravir in treating HIV. Studies have shown that this combination is effective, with 72.2% of participants achieving very low virus levels in their blood. Another study found that 92% of people maintained low virus levels after switching to this treatment. These results suggest that doravirine and islatravir together help control the virus. The treatment is also well-tolerated, meaning most people don't experience severe side effects. Overall, research indicates that this combination could be a promising option for managing HIV.12456

Who Is on the Research Team?

JE

Jordan E Lake, MD, MSc

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for people living with HIV who have their virus under control (virologically suppressed) and are currently on specific antiretroviral therapy regimens. Participants should be stable on treatment and meet other health requirements set by the study.

Inclusion Criteria

Able and willing to provide informed consent and undergo study procedures
HIV-1 RNA less than 50 copies/mL at screening and less than or equal to 200 copies/mL within 6 months of entry (verified by repeat HIV-1 RNA if needed)
I have been on my current HIV treatment for at least 6 months.
See 1 more

Exclusion Criteria

I have a chronic Hepatitis C infection.
I have advanced liver disease (Child-Pugh Class B or C).
Any condition, therapy, laboratory abnormality or circumstance that may confound study results or interfere with participation as judged by site investigator
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants switch to Doravirine/Islatravir or continue standard of care ART to assess effects on biologic aging

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Doravirine
  • Islatravir

Trial Overview

The study compares switching to a new HIV medication combination called doravirine/islatravir (DOR/ISL) versus staying on current standard antiretroviral therapy, to see how these affect markers of biological aging in the body.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Group 2Experimental Treatment1 Intervention
Group II: Group 1Experimental Treatment1 Intervention
Group III: Group 3Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Citations

Merck Presents New Data from Ongoing Phase 2b Clinical ...

Overall, 72.2% (n=65/90) of the combined islatravir with doravirine groups had HIV-RNA levels <50 copies/mL, which was similar to 77.4% (n=24/31) ...

Efficacy and safety of doravirine/islatravir in heavily treatment ...

From days 1 to 8, an at least 1.0 log10 decrease in HIV-1 RNA was achieved in 85.7% of the DOR/ISL group compared with 0 in the placebo group. At week 49, HIV-1 ...

Efficacy and safety of doravirine/islatravir for HIV-1

Primary outcomes were virological suppression (<50 copies/mL) and mean change in CD4+ T-cell count at week 48. Data were pooled using random-effects models.

Phase 3 DOR/ISL Shows Promise for HIV Treatment

Doravirine/islatravir may be a new HIV treatment option coming down the pike, according to new encouraging results from phase 3 data ...

Doravirine/Islatravir (100/0.75 mg) Once-Daily Compared With ...

Doravirine/islatravir (100/0.75 mg) once-daily was noninferior to bictegravir/emtricitabine/tenofovir alafenamide through week 48 for initial HIV-1 treatment.

NCT04223778 | Safety and Efficacy of a Switch to ...

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency ...