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Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS

Information source: AIDS Clinical Trials Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection

Intervention: Coformulated EFV/FTC/TDF (Drug); Etoposide (Drug); Bleomycin and Vincristine (BV) (Drug); Paclitaxel (PTX) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AIDS Clinical Trials Group

Official(s) and/or principal investigator(s):
Margaret Borok-Williams, MD, Study Chair, Affiliation: University of Zimbabwe
Susan E Krown, MD, Study Chair, Affiliation: AIDS Malignancy Consortium


This study is being done to compare the safety and efficacy of three combination treatments for Kaposi's Sarcoma and AIDS.

Clinical Details

Official title: A Randomized Comparison of Three Regimens of Chemotherapy With Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Lack of clinical efficacy

Secondary outcome:

Death by week 48

KS progression by week 48

AIDS-defining event by week 48

HIV-1 RNA virologic failure by week 48

Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) by week 48

KS tumor response by week 48

Duration of KS tumor response

KS progression, death, or AIDS defining event by week 48

KS progression, death, AIDS defining event, or virologic failure by week 48

KS progression, death, AIDS defining event, virologic failure, or KS-IRIS by week 48

Time to KS progression or death

Time to death

Change in KS treatment by week 48

Chemotherapy-related toxicities and Adverse Events (AEs) (e.g., Peripheral Neuropathy (PN))

Changes in CD4+ lymphocyte cell count

Adherence to therapy

Plasma KS-associated herpesvirus (KSHV)

Salivary KSHV

Peripheral blood mononuclear cell (PBMC) KSHV

Presence of oral KS

RNA levels for KSHV genes

Peripheral neuropathy (PN)

Symptomatic peripheral neuropathy (SPN)

Immunohistochemical evaluations of viral and cellular gene expression

Quality of life measures

Cellular and humoral markers of immune function and activation


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria for Step 1:

- HIV-1 infection

- Biopsy diagnostic of KS at any time prior to study entry.

- Current KS stage T1 using ACTG criteria.

- A minimum of five indicator KS cutaneous marker lesions plus an additional two

lesions greater or equal to 4x4 mm that are accessible for punch biopsy.

- CD4+ lymphocyte cell count obtained within 28 days prior to study entry at a

DAIDS-approved laboratory.

- Certain laboratory values, as defined in the protocol, obtained within 14 days prior

to study entry.

- Cardiac ejection fraction of greater than or equal to 50% obtained within 14 days

prior to study entry.

- Female study volunteers of reproductive potential must have a negative serum or urine

pregnancy test with a sensitivity of at least 50 mIU/mL performed within 24 hours before initiating the protocol-specified medications.

- All participants must agree not to participate in a conception process (active

attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).

- If participating in sexual activity that could lead to pregnancy, participant must

agree that two reliable forms of contraceptives will be used simultaneously while receiving protocol-specified medications, and for 6 weeks after stopping the medications. Study volunteers who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraceptives.

- Ability to swallow oral medications and adequate venous access.

- Karnofsky performance status ≥ 60 within 28 days prior to entry.

- Ability and willingness of participant or legal guardian/representative to provide

informed consent. Exclusion Criteria for Step 1:

- Current chronic, acute, or recurrent serious infections for which the participant has

not completed at least 14 days of therapy prior to Step 2 entry and/or is not clinically stable.

- Serious illness requiring systemic treatment and/or hospitalization within 14 days

prior to entry.

- Current or history of known pulmonary fibrosis, chronic obstructive pulmonary disease

(COPD), emphysema, bronchiectasis, or diffuse or significant local radiographic interstitial infiltrates on chest x-ray (CXR) or computed axial tomography (CAT).

- Oxygen saturation less than 90% and/or exercise desaturation greater than 4% within

14 days prior to study enrollment.

- Grade ≥3 peripheral neuropathy (PN) at entry.

- Breastfeeding.

- Receipt of ART for more than 28 days immediately prior to entry.

- Prior or current systemic or locally administered chemotherapy.

- Prior or current radiation therapy.

- Prior or current immunotherapy, e. g., interferon alfa.

- Corticosteroid use at doses above those given as replacement therapy for adrenal

insufficiency within the last 30 days prior to study entry.

- Any immunomodulator, HIV vaccine, live attenuated vaccines, or other investigational

therapy or investigational vaccine within 30 days prior to study entry.

- Known allergy/sensitivity or any hypersensitivity to components of study drugs or

their formulation.

- Active drug or alcohol use or dependence that would interfere with adherence to study


- Current or anticipated receipt of any of the prohibited medications listed in section

5. 5.2 of the protocol.

- In the opinion of the investigator, any psychological or social condition, or

addictive disorder that would preclude compliance with the protocol.

- New York Heart Association Functional Class II-IV heart failure.

Locations and Contacts

Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro 21045, Brazil; Recruiting
Sandra W. Cardoso, Phone: 552-125-644933, Email: sandra.wagner@bol.com.br
Beatriz Grinsztejn, MD, PhD, Principal Investigator

Moi University International Clnical Trials Unit, Eldoret 30100, Kenya; Recruiting
Kipruto Kirwa, Phone: 254-53-20-60850, Email: kkr380@yahoo.com

KMRI / Walter Reed Project Clinical Research Center, Kericho, Kenya; Recruiting
Hellen Ngeno, Phone: (254 52) 30686, Email: hngeno@wrp-kch.org

Univ. of Malawi, John Hopkins Project, Blantyre, Malawi; Recruiting
Sima TM Berendes, MPH, Phone: 265-018-60132, Email: sberendes@jhu.medcol.mw
Johnstone Kumwenda, MD, Principal Investigator

Durban Adult HIV CRS (11201), Durban 4013 SF, South Africa; Recruiting
Fawzia Williamson, Phone: 27 31 260 4365, Email: amodf1@nu.ac.za
Umesh Gangaram Lalloo, MD, FRCP, Principal Investigator

University of Witwatersrand, Johannesburg, South Africa; Recruiting
Pauline S Vunandlala, BSc., Phone: 27 11 717 2810, Email: idsyndicate@witshealth.co.za

Uganda Cancer Institute ACTG CRS, Kampala, Uganda; Recruiting
Jackson Orem, MB, ChB, MMED, Phone: 256-414540410

UZ-Parirenyatwa CRS (30313), Harare, Zimbabwe; Recruiting
Jimijika Batani, B.A., Phone: 263-912272818, Email: jbatani@uz-ucsf.co.zw
James Hakim, MD, MSc, FRCP, Principal Investigator

Additional Information

Starting date: August 2013
Last updated: July 6, 2015

Page last updated: August 20, 2015

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