Anti-HIV Medications for the Prevention of HIV Infection in Latin American Men Who Have Sex With Men - Full Text View

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00350324

Purpose

The purpose of this study is to evaluate the safety and effectiveness of daily emtricitabine/tenofovir DF (FTC/TDF) in preventing HIV transmission in HIV-1 uninfected men who have sex with men (MSM) in Peru and Ecuador.

Condition	Intervention	Phase
HIV Infection	Drug: Emtricitabine/Tenofovir DF Drug: FTC/TDF placebo	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Chemoprophylaxis for HIV Prevention in Men

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

HIV infection [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Creatinine toxicity of Grade 1 or higher [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Phosphorous toxicity of Grade 3 or higher [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Grade 2, 3, or 4 laboratory adverse events other than creatinine or phosphorous toxicity [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Grade 2, 3, or 4 clinical adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number and proportion of hepatitis B surface antigen- (HBsAg)-positive participants who experience sustained hepatic flares during and after treatment with FTC/TDF [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Changes in bone mineral density or proportion of fat in the limbs compared to baseline [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Frequency of drug resistance within 4 weeks of the first reactive HIV antibody test [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Plasma HIV-1 RNA level (viral load) and CD4 counts [ Time Frame: At 24 weeks after HIV infection ] [ Designated as safety issue: No ]
Participant responses to Computer Assisted Structured Interviews (CASI) about risk behavior, adherence to study drugs, and attitudes about HIV risk and adherence [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	1400
Study Start Date:	September 2009
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive daily FTC/TDF for 18 months	Drug: Emtricitabine/Tenofovir DF antiretroviral
2: Placebo Comparator Participants will receive daily placebo for 18 months	Drug: FTC/TDF placebo Placebo of Emtricitabine/Tenofovir DF

Detailed Description:

Even though countries in Latin America have implemented prevention programs known to lower HIV transmission rates, including interventions that promote abstinence, monogamy, condoms, and voluntary testing and counseling, HIV infections are still increasing. Even in Peru and Ecuador, where appropriate prevention measures have been implemented, MSM continue to practice inconsistent condom use, placing this group at high risk for HIV transmission. New approaches to HIV prevention are needed to address limitations in current prevention strategies. This study will evaluate whether daily FTC/TDF is safe and effective in preventing transmission of HIV among MSM in Peru and Ecuador.

This study will last 21 months. Participants will be randomly assigned to receive either daily FTC/TDF or placebo for 18 months. Study visits will occur monthly until Month 18, followed by monthly follow-up visits until Month 21. HIV testing will occur at every study visit. Blood collection, behavioral interviews, physical exams, and urine analysis will occur during most visits.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

HIV-uninfected
Engaging in any of the following high risk behaviors:
- No condom use during the last receptive or insertive anal intercourse
- Inconsistent condom use with sexual partner infected with HIV
- Anal intercourse with more than 5 sex partners in the 6 months prior to study entry
- Exchanged money, gifts, drugs, or shelter for anal sex in the 6 months prior to study entry
- Sexually transmitted disease (STD) diagnosis in the 6 months prior to study entry
Spanish-speaking

Exclusion Criteria:

Repeated positive urine tests for glycosuria and proteinuria
Previously diagnosed active or serious infections, including:
- Active tuberculosis infection or osteomyelitis and any infections requiring parenteral antibiotic therapy
- Active clinically significant cardiac disease (ischemia, congestive heart failure, or arrhythmia), pulmonary disease (steroid-dependent chronic obstructive pulmonary disease), or diabetes requiring hypoglycemic medication
- Previously diagnosed malignancy expected to require further treatment
History of pathological bone fractures not related to trauma
Receiving ongoing therapy with any of the following:
- Highly active antiretroviral therapy (HAART), including nucleoside reverse transcriptase inhibitors (NRTIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), and fusion inhibitors
- Interferon (alpha, beta, or gamma) or interleukin therapy
- Medications with significant kidney-damaging potential
- Medications that may inhibit or compete for elimination via active renal tubular secretion
- Investigational medications
Active alcohol or drug use that, in the opinion of the study investigator, may interfere with the study
Any other criteria that, in the opinion of the study investigator, may interfere with the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350324

Locations

Peru, Loreto
Asociacion Civil Selva Amazonica
Iquitos, Loreto, Peru

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	Robert M. Grant, MD, MPH	Gladstone Institute of Virology and Immunology, University of California, San Francisco
Study Chair:	Javier R. Lama, MD, MPH	Asociación Civil Impacta Salud y Educación, Lima, Peru

More Information

Click here for information on emtricitabine/tenofovir DF This link exits the ClinicalTrials.gov site

Click here for more information on understanding HIV prevention This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Publications:

Jackson JB, Barnett S, Piwowar-Manning E, Apuzzo L, Raines C, Hendrix C, Hamzeh F, Gallant J. A phase I/II study of nevirapine for pre-exposure prophylaxis of HIV-1 transmission in uninfected subjects at high risk. AIDS. 2003 Mar 7;17(4):547-53.

Van Rompay KK, McChesney MB, Aguirre NL, Schmidt KA, Bischofberger N, Marthas ML. Two low doses of tenofovir protect newborn macaques against oral simian immunodeficiency virus infection. J Infect Dis. 2001 Aug 15;184(4):429-38. Epub 2001 Jul 16.

Lifson JD, Rossio JL, Arnaout R, Li L, Parks TL, Schneider DK, Kiser RF, Coalter VJ, Walsh G, Imming RJ, Fisher B, Flynn BM, Bischofberger N, Piatak M Jr, Hirsch VM, Nowak MA, Wodarz D. Containment of simian immunodeficiency virus infection: cellular immune responses and protection from rechallenge following transient postinoculation antiretroviral treatment. J Virol. 2000 Mar;74(6):2584-93.

Rosenwirth B, ten Haaft P, Bogers WM, Nieuwenhuis IG, Niphuis H, Kuhn EM, Bischofberger N, Heeney JL, Uberla K. Antiretroviral therapy during primary immunodeficiency virus infection can induce persistent suppression of virus load and protection from heterologous challenge in rhesus macaques. J Virol. 2000 Feb;74(4):1704-11.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	Peru PrEP
Study First Received:	July 6, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00350324
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

HIV Seronegativity
Men who have Sex with Men
MSM
Truvada

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Emtricitabine
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Tenofovir
Retroviridae Infections
Immunologic Deficiency Syndromes
Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009