Maraviroc on HIV-1 Infected Subjects Who Require Allogeneic Hematopoietic Cell Transplant

Inclusion Criteria (Step 1)

- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or
chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and
confirmed by a licensed Western blot or a second antibody test by a method other than
the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL.

- Receipt of allo-HCT for any indication at least 100 days prior to study entry.

- Receipt of maraviroc for at least 30 days starting at date of transplant. Longer
receipt of maraviroc is acceptable. Documentation of HIV-1 tropism for CCR5 should be
obtained if available, but it is not necessary that the participant have prior
CCR5-tropic.

- At least 18 years of age.

- HIV-1 RNA that is <50 copies/mL using a FDA-approved assay performed by any laboratory
that has a CLIA certification or its equivalent within 45 days prior to study entry.

- For females of reproductive potential (i.e., women who have not been post-menopausal
for at least 24 consecutive months, who have had menses within the preceding 24
months, or women who have not undergone surgical sterilization, specifically
hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy), negative urine
pregnancy test (with a sensitivity of 15-25 mIU/mL) within 48 hours prior to screening
and entry.

- Negative HBsAg result obtained within 6 months prior to study entry, or documentation
of HBV immunity by positive HBV sAb at any time

- The following laboratory values obtained within 45 days prior to enrollment:

- CD4+ T cell count >250 cells/ mm^3

- Absolute neutrophil count (ANC) ≥1000 cells/mm^3

- Hemoglobin ≥10.0 g/dL for men and ≥9.0 g/dL for women

- Platelet count ≥ 50,000/mm3

- Ability and willingness of participant or legal representative to provide informed
consent.

Additional Inclusion Criteria for Step 2 of Study:

- HIV-1 latent reservoir undetectable by co-culture and DNA

- No confirmed detectable HIV-1 RNA > 1000 cells/mm3 since discontinuation of maraviroc

- Prior HIV-1 genotype results that confirm that there are active agents available in at
least three classes of ART drugs (NRTI, NNRTI, PI or integrase).

- Willing to stop ART

- Willing to undergo high volume blood draw (125 cc) at Week 16

- Willing to restart ART if HIV-1 viremia returns

- Provide informed consent for Step 2

Exclusion Criteria:

- Ongoing AIDS-related opportunistic infection (including oral thrush).

- Pregnant and/or breastfeeding.