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This study evaluates whether adding the CCR5 inhibitor Maraviroc improves immune recovery in HIV patients whose CD4+ T-cell count stays low despite HIV therapy. It included patients on stable HIV treatment with a CD4 count below 350. It was a Phase 4 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria:
1. HIV-1 infection
2. All available CD4+ T cell counts within the last 12 months of screening below 350 cells/mm3 (minimum of 3 values obtained \> 30 days apart).
3. HIV treatment with a stable (for at least 6 months) antiretroviral regimen consisting of at least 2 NRTIs and either a protease inhibitor boosted with low dose ritonavir or an NNRTI. A stable regimen is defined as no additions or deletions for more than 14 cumulative days.
4. Patient considered to be receiving initial HIV regimen (history of medication substitution for toxicity is allowed).
5. All available plasma HIV RNA levels within the last 12 months are below the level of detection. Isolated values that are detectable but \< 1000 copies will be allowed as long as the plasma HIV RNA levels before and after this detectable time point are undetectable - The subject should have a minimum of 3 values obtained \> 30 days apart.
6. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
7. Men and women age ≥ 18 years.
Exclusion Criteria:
1. Current antiretroviral regimen contains tenofovir disoproxil fumarate AND didanosine in combination.
2. History of chronic hepatitis C (defined as HCV antibody positive and HCV RNA detectable).
3. History of chronic active hepatitis B (defined as surface antibody negative, surface antigen positive and HBV DNA detectable).
4. Concurrent use of G-CSF or GM-CSF.
5. Prior or concurrent use of IL-2.
6. Prior or concurrent use of a CCR5 inhibitor.
7. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
8. Use of any immunomodulator, HIV vaccine, or investigational therapy within 30 days of study entry.
9. Use of human growth hormone within 30 days prior to study entry.
10. Initiation of testosterone or anabolic steroids within 30 days prior to study entry. (Exception: Chronic replacement dosages in patient's with diagnosed hypogonadism is allowed).
11. Evidence of splenic sequestration or suppressed bone marrow function:
* Clinical or radiographic evidence of significant splenomegaly.
* History of leukemia or lymphoma.
* History of myelosuppressive chemotherapy or irradiation