Could an HIV drug boost cervical cancer treatment?
NCT ID NCT03256916
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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348 people
The number who actually took part.
- Started
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Jan 2018
- Finished
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May 2024
- Lead sponsor
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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
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18 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Tata Memorial Centre
Mumbai, Maharashtra, 400012, India