The subjects in this arm will receive Maraviroc as treatment, while continuing their current antiretroviral medication regimen.

Kaposi's Sarcoma

FDA Recommended dosing will be used in this study. Subjects on an efavirenz or etravirine-based regimen will be dosed at 600 mg orally, twice per day, for 96 weeks.
Subjects on a ritonavir-boosted protease inhibitor based regimen (except for tipranavir/ritonavir) will be dosed at 150 mg orally, twice per day, for 96 weeks.
Subjects that are on regimens that do not include etravirine, efavirenz, or ritonavir will be dosed at 300mg orally, twice per day, for 96 weeks. These doses are based on the recommendations from the company based on drug-drug interactions.

Maraviroc

San Francisco General Hospital, Clinical Trials Unit

Effects of Maraviroc (MVC) on HIV-related Kaposi's Sarcoma (KS)

The subjects' Kaposi's sarcoma related lesions will be evaluated during each visit for an increase or decrease in the number of lesions and whether the quality of the lesions show improvement or worsening of the condition.

A biopsy will be taken from the subjects' lesions at baseline and at the end of the study to determine whether there has been a change in CCR5 receptor levels or KSHV levels.

Blood samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in CD4 count or HIV viral load.

Blood and saliva samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in KSHV viral load.

Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells.

Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in T cell activation and exhaustion.

University of California, San Francisco

Pfizer

ViiV Healthcare

Herpes Simplex II

Twice-daily vaginal application of 3.5 g of VivaGel™ (Carbopol®-based gel with 3% w/w SPL7013) in single use pre-filled applicators.

3% w/w SPL7013 Gel

Placebo gel (Carbopol®-based formulation alone) in single use pre-filled applicators.

Placebo

University of California San Francisco

Kenya Medical Research Institute

VivaGel™ in Healthy Young Women

An Expanded Phase I Randomized Placebo Controlled Trial of the Safety and Tolerability of 3 Percent w/w SPL7013 Gel (VivaGel™) in Healthy Young Women When Administered Twice Daily for 14 Days

herpes genitalis/protease

Effects of Maraviroc (MVC) on HIV-related Kaposi's Sarcoma (KS)

VivaGel™ in Healthy Young Women

Evolution of L74V or K65R Mutations in VIremic Subjects on Tenofovir Disoproxil Fumarate (TDF) or Abacavir (ABC) (EVITA)

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