Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV-1 Infection

In brief

The main purpose of this study was to compare the effects on bones of the following two drug combinations: * maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r) * tenofovir (TDF) plus emtricitabine (FTC) plus darunavir/ritonavir (DRV/r) Additional study objectives were the following: * To see how the drug combinations affect the brain and kidneys. * To see how well the drug combinations lower the HIV viral load. * To see how safe the drug combinations are, how well people are able to take the study drug combinations, and how well their immune systems respond to the study drugs.

Key facts

Study ID

NCT01400412

Run by

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

People needed

262

Starts

2012-01-17

Expected to finish

2014-06-30

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infection
• No evidence of exclusionary resistance mutations defined as evidence of any major NRTI mutation according to the current IAS list of HIV-1 Resistance Mutations Associated with Drug Resistance, or any DRV RAMs (refer to the A5303 PSWP for a list of these mutations) on any genotype; or evidence of significant NRTI or DRV resistance on any phenotype performed at any time prior to study entry. NNRTI-associated resistance mutations were not exclusionary.
• ARV drug-naïve, defined as </=10 days of ART at any time prior to study entry, except in the instances defined in section 4.1.3 of the protocol.
• R5-only tropism based on Trofile testing performed within 90 days prior to study entry.
• Screening HIV-1 RNA >1000 copies/mL obtained within 90 days prior to study entry by any FDA-approved test for quantifying HIV-1 RNA at any laboratory that has a CLIA certification or its equivalent.
• Known hepatitis C virus (HCV) antibody status (performed at any laboratory that had a CLIA certification or its equivalent).
• Certain laboratory values obtained within 60 days prior to study entry, as defined in section 4.1.7 of the protocol.
• For women of reproductive potential, negative serum or urine pregnancy test with a sensitivity of ≤25 mIU/mL within 72 hours prior to study entry.
• Female subjects of reproductive potential, who were participating in sexual activity that could lead to pregnancy, must agree to use at least one reliable method of contraception (as defined in section 4.1.9.1 of the protocol) while receiving the study drugs and for 6 weeks after stopping the medications.
• Female subjects who were not of reproductive potential or whose male partner(s) had azoospermia were eligible to take study drugs without the use of contraceptives.
• Ability and willingness of subject or legal guardian/representative to give written informed consent.
• Willingness to undergo neuropsychological testing.
• DXA scan performed after confirmation of the subject's eligibility by Trofile testing but no more than 4 weeks prior to randomization.

You may not qualify if…

• Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry.
• New use of hormonal therapies within 6 months prior to study entry. (Stable therapy for ≥6 months was permitted.)
• New use of oral contraceptive pills (OCPs) in the past 3 months. (Stable therapy for ≥3 months was permitted.)
• Any oral, intravenous, or inhaled steroids within 30 days prior to study entry. (Intranasal steroids and topical corticosteroids were allowed.)
• Known allergy/sensitivity to study drugs or their formulations. (A history of sulfa allergy was not an exclusionary condition.)
• Known hypersensitivity to soy lecithin.
• Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or was clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry. (Oral candidiasis, vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses (as judged by the site investigator) were not exclusionary conditions.)
• Requirement for any current medications that were prohibited with any study drugs. (Prohibited medications must be discontinued at least 30 days prior to entry. Refer to the A5303 PSWP for a list of prohibited medications.)
• The presence of decompensated cirrhosis.
• A history of or current, active HBV infection defined as positive hepatitis B surface antigen test (or positive HBV DNA in subjects with isolated HBcAb positivity, defined as negative HBsAg, negative HBsAb, and positive HBcAb) at screening.
• Current or prior use of biphosphonates, teriparatide, raloxifene, or denosumab.
• Weight >300 lbs (exceeds weight limit of DXA scanners).
• History after 18 years of age of fracture of the spine, hip, wrist, or other site thought to be related to osteoporosis or bone fragility.
• Currently breastfeeding.
• Any active psychiatric illness including schizophrenia, severe depression, or severe bipolar affective disorder that, in the opinion of the investigator, could confound the analysis of the neurological examination or neuropsychological test results.
• Active drug or alcohol abuse that, in the investigator's opinion, could prevent compliance with study procedures or confound the analysis of study endpoints.
• Active brain infection (except for HIV-1), fungal meningitis, toxoplasmosis, central nervous system (CNS) lymphoma, brain neoplasm, or space-occupying brain lesion requiring acute or chronic therapy.

Where it is running

• 31788 Alabama CRS — Birmingham, Alabama, United States
• University of Southern California (1201) — Los Angeles, California, United States
• UCLA CARE Center CRS (601) — Los Angeles, California, United States
• Ucsd, Avrc Crs (701) — San Diego, California, United States
• Ucsf Aids Crs (801) — San Francisco, California, United States
• University of Colorado Hospital CRS (6101) — Aurora, Colorado, United States
• University of Colorado Denver ATN CRS (33022) — Denver, Colorado, United States
• Georgetown University CRS (GU CRS) (1008) — Washington D.C., District of Columbia, United States
• Children's National Med. Ctr. ATN CRS (33003) — Washington D.C., District of Columbia, United States
• Univ. of Miami AIDS CRS (901) — Miami, Florida, United States
• Univ. of South Florida (USF) College of Medicine ATN CRS (33001) — Tampa, Florida, United States
• The Ponce de Leon Center CRS (5802) — Atlanta, Georgia, United States
• Northwestern University CRS (2701) — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS (2702) — Chicago, Illinois, United States
• IHV Baltimore Treatment CRS (4651) — Baltimore, Maryland, United States
• 201 Johns Hopkins University CRS — Baltimore, Maryland, United States
• Massachusetts General Hospital ACTG CRS (101) — Boston, Massachusetts, United States
• Brigham and Women's Hosp. ACTG CRS (107) — Boston, Massachusetts, United States
• Washington U CRS (2101) — St Louis, Missouri, United States
• Cooper Univ. Hosp. CRS (31476) — Camden, New Jersey, United States
• Columbia Physicians and Surgeons CRS (30329) — New York, New York, United States
• Trillium Health ACTG CRS (1108) — Rochester, New York, United States
• University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787) — Rochester, New York, United States
• Unc Aids Crs (3201) — Chapel Hill, North Carolina, United States
• Moses H. Cone Memorial Hospital CRS (3203) — Greensboro, North Carolina, United States

Full record on ClinicalTrials.gov

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