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Could an HIV drug boost cervical cancer treatment?

NCT ID NCT03256916

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding the HIV drug nelfinavir to standard chemoradiation helps people with advanced cervical cancer stay cancer-free longer. About 348 adults with stage III cervical cancer took part. One group got standard treatment, and the other got nelfinavir before and during treatment. The goal was to see if the drug improves 3-year disease-free survival.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

348 people

The number who actually took part.

Started

Jan 2018

Finished

May 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 65 years

Sex

Female 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 * ECOG 0 to 2 * FIGO 2018 Stage IIIA (TNM stage T3a N0 M0) FIGO 2018 Stage IIIB (TNM stage T3b N0 M0) FIGO 2018 Stage IIIC (TNM stage Any T N1 M0) * No previous irradiation to the pelvis or chemotherapy * Age 18 years and above * Ability to tolerate full course of pelvic radiotherapy and brachytherapy * Adequate bone marrow, liver, and kidney function defined as neutrophil count ≥ 1500 platelet count ≥ 100,000, total bilirubin less than 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN, and creatinine less than 1.5 upper limit of normal or Creatinine clearance greater than 60 mL/min/1.73 m2 * No recent (less than 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction) * Ability to understand and the willingness to sign an informed consent document * Should be willing to undergo extra biopsy and blood collection for pharmacokinetic studies Exclusion criteria * Patients with newly diagnosed diabetes , uncontrolled DM (patient with HbA1c of \> 6.5% or FBS value or BSF\>=126 mg/dL respectively on primary evaluation) * Pts on any drugs which has pharmacological interaction with nelfinavir: * Terfenadine, cisapride, sildenafil, lovastatin or simvastatin and medication that are metabolized by the CYP3A4 isoenzyme. * Antiarrhythmics (amiodarone, quinidine). * Neuroleptics (pimozide). * Sedative/Hypnotic agents (midazolam, triazolam). * Ergot derivatives. * HMG-CoA reductase inhibitors (atorvastatin). * Rifampicin, Rifabutin. * Felodipine, Nifedipine. * Pregnant or lactating * Active co existing malignancy. * HIV positive patients will be excluded. * Patients with hemophilia. * Patients with reduced creatinine clearance ( less than 50 ml/ min) or unilateral or bilateral hydronephrosis will be excluded. * History of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

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Conditions

The condition(s) this trial relates to.

cervical carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

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

Contacts and locations

Locations

  • Tata Memorial Centre

    Mumbai, Maharashtra, 400012, India