Immune Therapy and Analytical Treatment Interruption in HIV+ Participants Who Received an Allogeneic Stem Cell Transplantation

• Status: Suspended
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The availability of antiretroviral therapy (cART) for HIV-1 infection has led to a reduction in morbidity in patients with chronic HIV infection. However, cART does not eliminate HIV-1 that persists as a latent infection in cellular reservoirs. Usually, HIV viremia rapidly rebounds if antiretroviral therapy is interrupted. Consequently, HIV infected individuals must commit to expensive, life-long therapies and must tackle problems associated with chronic infection and uninterrupted cART, including continuous clinical and laboratory monitoring, drug toxicities, and chronic immune activation/inflammation.

Currently, there is an emerging interest in developing safe and affordable curative strategies that would eliminate the need for lifelong therapy. However, to date only allogeneic hematopoietic stem cell transplantation (allo-HSCT) has shown results in decreasing the HIV-1 reservoirs.

The IciStem Consortium (www.icistem.org) has assembled the largest and most exhaustive observational cohort for the study of HIV reservoir dynamics in allo-HSCT HIV+ individuals with severe hematological malignancies worldwide. Within the cohort, only individuals transplanted with a donor with thw CCR5A32 mutation have shown signs of HIV remission. On the other side broadly neutralizing antibodies (bNAbs) have shown the potential to control HIV infection. This study intends to evaluate if the allo-HSCT combined with the additional application of bNAbs is effective to control HIV replication.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IrsiCaixa

Criteria

Inclusion Criteria:

• More than 2 years post-HSCT

• Being off immunosuppression for at least one year (related to allo-HSCT)

• Undetectable levels of HIV replication competent reservoirs in blood (< 0,1 IUPM).

• CD4 count levels higher than 200 cel/mm3.

• Aged at least 18 years and not older than 65 at the day of screening

• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.

• In the opinion of the principal investigator or designee, the participant has understood the information provided and capable of giving written informed consent.

• If heterosexually active female; using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner1) from 14 days prior to the first bNAbs administration until at least 6 months after the last bNAbs administration; all female volunteers must be willing to undergo urine pregnancy tests at time points specified.

• If heterosexually active male; willing to use an effective method of contraception (anatomical sterility in self) or agree on the use of an effective method of contraception by his partner(hormonal contraception, intra-uterine device (IUD), or anatomical sterility1 from the day of the first bNAbs administration until 6 months after the last bNAbs administration.

• Willing to accept blood draws at time points specified.

• Not sharing injection drug equipment, such as needles.

1. Condom use nor diaphragm are considered as an additional method of contraception only and cannot be the only method of contraception used as not been considered an effective method by the Clinical Trial Facilitation Group (CTFG) guidelines.

Exclusion Criteria:

• Pregnancy or lactating

• Participation in another clinical trial within 12 weeks of study entry (at screening period).

• History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete the study.