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New hope for HIV patients with Hard-to-Treat hepatitis c

NCT ID NCT00901524

Disease control Sponsor: ANRS, Emerging Infectious Diseases 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a more intensive hepatitis C treatment in 58 adults who have both HIV and hepatitis C (genotypes 1 or 4) and had not responded to previous therapy. Participants received higher doses of two drugs, peginterferon alfa-2a and ribavirin, for up to 18 months. The goal was to see if this approach could clear the hepatitis C virus from the body for at least six months after treatment ended.

What this could mean

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

Active substance
Peginterferon alfa-2a and ribavirin
What this could lead to
If successful, this could offer a more effective treatment option for people with both HIV and hepatitis C who have not responded to standard therapy.
What could go wrong
This is a small, early-phase study with only 58 participants. The treatment involves strong drugs that can cause side effects, and results may not apply to all patients.

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

58 people

The number who actually took part.

Start date

Jun 2009

Finished

Jun 2012

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 years and older

Sex

Anyone

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: * Age over 18 years * Weight 85 kg below the pre-inclusion visit. * Documented HIV infection (HIV positive) * HCV infection documented by a positive PCR * HCV Genotype 1 or 4 * Compensated liver disease (Child-Pugh below/equal to 6) * Lymphocytes CD4 above 200/mm3 * Patient not answering a treatment for hepatitis C. * Patient not covered by dual by Peg-IFN + riba for at least three months (wash out) Exclusion Criteria: * Co-infection with HBV (HBsAg positive) * Neutropenia below 1000/mm3 * Thrombocytopenia below 90000/mm3 or thrombocytosis over 500 000/mm3. * Hemoglobin below 11 g / dL (men and women) * Arguments radiological (ultrasound, CT or MRI) of hepatocellular carcinoma cell * Antiretroviral containing didanosine (ddI) and stavudine (d4T) and zidovudine (AZT) and abacavir (ABC).

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Conditions

The condition(s) this trial relates to.

hepatitis hepatitis C virus infection HIV infectious disease

As listed by the trial registrant

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

Hepatitis

Contacts and locations

Locations

  • Hôpital Tenon Service des Maladies Infectieuses

    Paris, 75970, France

More trials for these conditions

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