HIV PositiveNCT07167069
India HIV-CervCa Project
An observational study of HIV Positive and HIV Negative, run by Abramson Cancer Center at Penn Medicine at 1 site in India.
Trial summary
The investigators propose to prospectively study the difference in treatment (CTRT) completion and toxicities between HIV positive and HIV negative women in India with locally advanced cervical cancer receiving CTRT. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Positive, HIV Negative, Cervical Cancer
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- 9 Feb 2021to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cervical cancer at Tata Memorial Hospital in India.
Who may be able to join
- patients with newly biopsy proven squamous carcinoma or adenocarcinoma of the uterine cervix, FIGO stage IB2-IIIB in whom curative CTRT is planned
- Karnofsky performance status ≥ 70
- Patients with lower paraortic lymph nodes (below the level of L2 vertebra)
- patients diagnosed with cervical cancer whom also HIV positive or HIV negative
Who cannot join
- patients with active tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Treatment Adherence and Toxicities of HIV Positive Patients Versus HIV Negative Cervical Cancer Patients in India
The investigators propose to prospectively study the difference in treatment (CTRT) completion and toxicities between HIV positive and HIV negative women in India with locally advanced cervical cancer receiving CTRT.
Read the detailed description
This study will compare chemoradiation completion rates for cervical cancer in two groups, women with HIV and women without HIV. The investigators will also be analyzing tumor tissue for tumor infiltrating lymphocytes which are thought to be involved in disease progression.
- Conditions
- HIV Positive, HIV Negative, Cervical Cancer
- Being tested
- Radiation Therapy
- Keywords
- Chemotherapy, Concurrent Chemoradiotherapy, Radiotherapy
- Medical subject headings
- HIV Seropositivity, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Standard of Care Chemoradiation for Cervical cancer patients in India.
| Study group | Role | What they receive |
|---|---|---|
| HIV Positive | Cervical Cancer Patients with HIV positive Receives: Radiation: Radiation Therapy | |
| HIV Negative | Cervical Cancer Patients with HIV negative Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rates of Cancer Treatment
To evaluate and compare the completion rates of cancer treatment in HIV positive cervical cancer patients and HIV negative cervical cancer patients.
Treatment adherence is defined as receiving at least 5 cycles of weekly cisplatin chemotherapy and completion of all prescribed radiation (including brachytherapy) and chemotherapy within 8 weeks of treatment initiation.
Measured: 2 years
Impact of HIV Infection on acute toxicities
To compare the incidence of acute grade ≥3 gastrointestinal, genitourinary and hematological toxicities using CTCAE v4 in patients receiving concurrent cisplatin-based chemo-radiation and brachytherapy for cervical cancer in HIV positive and HIV negative patients. Acute toxicities include any toxicity occurring within 90 days of treatment completion.
Measured: 2 years
Secondary outcomes (1)
Tumor infiltrating lymphocytes (TILs)
To identify and characterize tumor infiltrating lymphocytes (TILs) with reference to numbers and phenotype in tumor biopsies of HIV positive and HIV negative cervical cancer patients in India
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start9 Feb 2021
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Tata Memorial Hospital, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Surbhi Grover, MD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167069
- Sponsor's protocol ID
- UPCC 20824
- Other IDs
- 834664, DAA3-19-65331-1
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Adherence and Toxicities of HIV Positive Patients Versus HIV Negative Cervical Cancer Patients in India
- ClinicalTrials.gov ID
- NCT07167069
- Acronym / sponsor ID
- UPCC 20824
- Conditions
- HIV Positive, HIV Negative, Cervical Cancer
- Keywords
- Chemotherapy, Concurrent Chemoradiotherapy, Radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Tata Memorial Hospital, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to prospectively study the difference in treatment (CTRT) completion and toxicities between HIV positive and HIV negative women in India with locally advanced cervical cancer receiving CTRT.
Detailed description
This study will compare chemoradiation completion rates for cervical cancer in two groups, women with HIV and women without HIV. The investigators will also be analyzing tumor tissue for tumor infiltrating lymphocytes which are thought to be involved in disease progression.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV Positive | – | Radiation: Radiation TherapyCervical Cancer Patients with HIV positive |
| HIV Negative | – | Radiation: Radiation TherapyCervical Cancer Patients with HIV negative |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cervical cancer at Tata Memorial Hospital in India.
Key inclusion criteria (4 listed)
- patients with newly biopsy proven squamous carcinoma or adenocarcinoma of the uterine cervix, FIGO stage IB2-IIIB in whom curative CTRT is planned
- Karnofsky performance status ≥ 70
- Patients with lower paraortic lymph nodes (below the level of L2 vertebra)
- patients diagnosed with cervical cancer whom also HIV positive or HIV negative
Key exclusion criteria (1 listed)
- patients with active tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyStandard of Care Chemoradiation for Cervical cancer patients in India. | Radiation | HIV Negative, HIV Positive |
Primary outcome
Completion Rates of Cancer Treatment
Time frame: 2 years
To evaluate and compare the completion rates of cancer treatment in HIV positive cervical cancer patients and HIV negative cervical cancer patients. Treatment adherence is defined as receiving at least 5 cycles of weekly cisplatin chemotherapy and completion of all prescribed radiation (including brachytherapy) and chemotherapy within 8 weeks of treatment initiation.
Impact of HIV Infection on acute toxicities
Time frame: 2 years
To compare the incidence of acute grade ≥3 gastrointestinal, genitourinary and hematological toxicities using CTCAE v4 in patients receiving concurrent cisplatin-based chemo-radiation and brachytherapy for cervical cancer in HIV positive and HIV negative patients. Acute toxicities include any toxicity occurring within 90 days of treatment completion.
1 secondary outcome
Tumor infiltrating lymphocytes (TILs)
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surbhi Grover, MD, MPH principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Positive and HIV Negative, run by Abramson Cancer Center at Penn Medicine at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rates of Cancer Treatment (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.