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New peptide aims to flush out hidden HIV in early trial

NCT ID NCT06799650

Disease control Sponsor: Federal University of São Paulo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 2 trial tests whether adding Gammora® (a peptide) to standard antiretroviral therapy can reduce the hidden HIV reservoir in people newly diagnosed with HIV. Forty participants who have never taken HIV drugs will be randomly assigned to receive either Gammora® plus standard drugs or standard drugs alone. The study measures changes in HIV DNA levels and cell death markers over 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gammora® (a peptide) plus standard antiretroviral drugs (Tenofovir, 3TC, Darunavir, Ritonavir)
What this could lead to
If successful, this could point toward a way to shrink the hidden HIV reservoir, potentially leading to better long-term control of the virus.
What could go wrong
This is a small, early-phase (Phase 2) trial with only 40 participants. The results may not be generalizable, and the treatment may not significantly reduce the HIV reservoir or cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Confirmed HIV infection; 2. Antiretroviral naive; 3. HIV Viral load \> 1.000; 4. CD4+ T cell counts \>350 cells/mm3; 5. Body weight \> 50 Kg; 6. Signed informed consent form. Exclusion Criteria: 1. BMI \< 18.5 kg/m2 at screening; 2. Coinfection with HBV (HBsAg +) or HCV; 3. Any significant acute illness within one week before the first visit. 4. Use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within four weeks before screening; 5. Active malignancy or malignancy in follow-up. 6. Changes in safety tests: neutrophil count \< 1,000 u/L; Hb \< 9.0 gm/dl; platelet count \< 75,000 u/L; creatinine \> 1.5 mg/dl, direct bilirubin \> 85 μmol/L, AST or ALT \> 2.5 X UNL; 7. Potential allergy or hypersensitivity to the components of the Gammora® formulation. 8. Participation in another clinical trial within 12 months before screening. 9. Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the investigator's discretion.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease HIV Seropositivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV seropositivity

Contacts and locations

Locations

  • RDSS

    São Paulo, São Paulo, 04039-032, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.