Investigating the effect of maraviroc on Microbial Translocation in HIV infected individuals who are receiving antiretroviral therapy

Phase 4

Completed

Conditions: Human immunodeficiency virus (HIV)
Infections and Infestations
Human immunodeficiency virus [HIV] disease

Registration Number: ISRCTN81045654

Lead Sponsor: Guys & St Thomas' NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 10

Inclusion Criteria

1. Males and females aged between 18-70 with confirmed human immunodeficiency virus (HIV)-1 infection
2. Patients on stable antiretroviral therapy for at least 12 months
3. Screening CD4+ T cell count below 350 cells/mm3
4. All available CD4+ T cell counts in the last year and at screening < 350 cells/mm3
5. Screening plasma HIV ribonucleic acid (RNA) levels below 100copies RNA/mL
6. All available plasma HIV RNA levels within past 6-months below the level of detection. Isolated values that are detectable but < 500 copies will be allowed as long as the plasma HIV RNA levels before and after this time point are undetectable.
7. 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 and at least 28 days after last dose of study drug. Effective methods include condoms in combination with a female condom, diaphragm, intrauterine device, hormonal contraceptives (oral, implants, injectable), abstinence, vasectomy or tubal ligation.
8. Ability and willingness of subject to provide informed consent

Exclusion Criteria

1. Patient unlikely to comply with protocol, and in particular adhere to therapeutic regimen
2. Patient likely to use narcotics during the study period
3. Increase in CD4 count of > 100 cells/mm3 in past year
4. Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason
5. Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
6. Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks
7. Hepatitis B surface antigen (HBVsAg+) or active hepatitis C or hepatitis B which will require treatment in the subsequent 24 weeks
8. Prior exposure to chemokine (C-C motif) receptor 5 (CCR5) inhibitors
9. Estimated creatinine clearance < 40 mL/minute
10. Pregnant or breastfeeding women
11. Use of both tenofovir and didanosine in current antiretroviral therapy regimen